01 June 2009

“Responses to comments” document for Dibutyl phthalate (DBP) (EC number: 201-557-4)

This document provides ECHA’s responses to the comments received during the public consultation on the draft recommendation for inclusion of substances in Annex XIV of REACH which took place between 14 January and 14 April 2009.   

I - Comments and responses to comments on the prioritisation

General comments on the prioritisation
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090206	Germany, industry association (on behalf of)	Page 1: Frankly spoken, we are very angry, that several SVHC substances like DBP, BBP, DEHP and HBCDD which will be used in many applications and which cannot be replaced by other substances, have to be now additionally authorized and listed application oriented although they have to be registered! This additional authorization and listing procedure has to be stopped promptly because it is contra productive and bureaucratic! We all know, that for many SVHC substances never will exist any substitution substances. That means it can happen, that many EU substance suppliers will stop their production of such SVHC substances completely because they don't want to start the authorization and listing procedure due to increasing administration cost. Therefore we ask you to stop this stupid authorization and listing procedure for the mentionned substances! If all these substances will disappear from the EU market due to authorization and listing procedure, many high advanced textile products can no more produced in the EU, with the effect, that they will come back as imports via semi-finished and finished textile products in the EU from Non-EU- as well as EU-Associated Countries. Innovative txtile companies in the EU have to close their plants with increasing unemployment rates in favour of Non-EU- as well as EU-Associated Countries where all these substances will be produced and used and applicated. With this stupid authorization and listing procedure you are killing our EU industries and their competitiveness in favour of Non-EU- as well as -Associated Countries. This is a big scandale and all European politicians and parties who voted for such a bureaucratic system have to be kicked out! We are living in most European countries from production and not from services like U.K. and Ireland! The financial crisis has shown that British and American uncontrolled finance and capital sytems do not work at all and that British and American bankers are not able to deal with money. Therefore strong world regulations have to be made and the EU has to strenghten the European production being competitive on the world market. With additional complicating REACH elements like authorization and listing of specific SVHC substances which never can be replacecd will strengthen producers in Non-EU- as well as -Associated Countries only! If once our producers in the EU should disappear due to over regulations you and our politicians will disappear too! 	We thank you for your comment.

With regard to concerns relating to the import of Substances of Very High Concern (SVHC) via (semi‑)finished articles, it should be noted that the REACH Regulation contains provisions that allow to identify and, if deemed necessary, restrict such imports of SVHC within articles:
•	importers (and producers) of articles are required to notify the presence of candidate substances (i.e. substances identified in accordance with Article 59 as meeting the criteria of Article 57) in articles when the substances are present in those articles above a concentration of 0.1% (weight/weight) and the quantity of a substance totals over 1 tonne per producer or importer per year. If such a substance is intended to be released and the same conditions regarding concentration and tonnage are met, the substance requires registration (see provisions or Article 7(1) and 7(2) of REACH),
•	if considered necessary, Community-wide measures restricting the placing on the market (including the import to the EU) of articles containing SVHC substances can be imposed. REACH Article 69(2) requests ECHA to consider whether the use in articles of a substance subjected to authorisation poses a risk to human health or the environment that is not adequately controlled. If ECHA considers that the risk is not adequately controlled, it shall prepare an Annex XV dossier addressing these risks. Further, the Member States can develop restriction proposals addressing such imports of SVHC with articles. The European Commission can take initiative as well and request ECHA to develop restriction proposals.
	
20090226	MSCA, United Kingdom	The pthalates have recently gone through through the Existing Substances Regulation, including the agreement of risk assessments and, where deemed necessary, a risk reduction strategy. There is a need to reflect on how this recently-established EU regulatory position sits alongside a proposal that these substances should now be subject to Authorisation. 	We thank you for your comment.

The three phthalates were proposed for inclusion in Annex XIV on the basis of the prioritisation approach applied by ECHA for this first recommendation. They clearly fulfil the criteria for high volume and wide dispersive use. On the basis of the information generated and assessed under the ESR which has to be taken into account by the applicant (Annex I section 0.5), it could be assumed that applicants are able to demonstrate adequate control of risk in accordance with section 6.4 of Annex I. Therefore, provided that the other application requirements will be fulfilled, it is not unlikely that an authorisation to use these substances can be obtained. However, authorisation applications need to include an analysis of alternatives. Where this analysis concludes that there are suitable alternatives available for the applicant, the application has to include also a substitution plan. Both the analysis of alternatives and, where available, the substitution plan can be used when defining a time-limited review period, any conditions or monitoring arrangements in the authorisation decision. The application requirements and the review obligation and any other decision conditions aim to promote substitution.	
20090313	Germany, company (on behalf of)	Proposal: To exempt from the authorisation requirement the placing on the market of SVHC in a preparation for the supply to industrial users for the use as analytical standard for test and measurement instruments.
Justification: Defined substance samples are required to calibrate analytical instruments to identify and quantify the substance (e.g. for measurement solutions used by enforcement agencies). The applications are laboratory use by professional users (minimal risk to consumers and the environment, controlled professional use and disposal). The volumes required for calibration samples (analytical standards) are minimal, typically a solution in the range of millilitres. The concentration of the chemical standard substance is normally low - in the range of 0.1%-2% and often lower according to the sensitivity of the measuring technique. For existing or future development of new highly sensitive analytical test solutions (e.g. using mass spectroscopy, chromatography, optical spectroscopy, etc.), the use of analytical standards for calibration purposes is indispensable and is required for deployment of technical verification instruments for operational enforcement of environmental policies. A substitution of the substance of concern is technically not possible due to the calibration purpose of the usage. Comment on Terminology: Analytical standards are sometimes also named chemical standards, calibration standards or samples or test samples. 	We thank you for your comment.

However, we would like to clarify that, according to Art. 56(3) of the REACH Regulation, the obligations of Art. 56(1) and 56(2) “shall not apply to the use of substances in scientific research and development”.
Hence, as defined in Art. 3(23) of REACH the placing on the market of a substance for any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year does not require authorisation.
ECHA is of the opinion that, provided that the use of the substance is actually in accordance with the definition of “scientific research and development” under REACH, and in particular fulfils its specific conditions, the placing on the market for this specific use does not require an authorisation.	
20090324	MSCA, The Netherlands	In general, the background documents and justification provided by ECHA are well prepared. On one important aspect NL disagree with the proposal from ECHA: according to us the fact that a substance can easily replaced by a an other substance in same group (in the case of diarsenic trioxide and sodium dichromate), is not an argument to de-prioritize the substance, because it other wise will be very hard to take care of problematic groups of substances. According to NL prioritisation of one of the substances in the group is a signal to industry that also these kind compounds are subject to the authorisation regime. NL used a ranking system to analyse the available information on hazard properties, manufacture, uses and releases: Aspect Points 1. PBT/vPvB no 0 yes 1 2. Volume low (10000 t/yr) 5 3. Use (number of point sources, potential for worker exposure, potential for consumer exposure) small/low 1 medium 2 many/high/widespread 3 4. Release non-diffuse/controlled insignificant 1 medium 2 diffuse/uncontrolled/significant 3 Following this analysis, HBCDD, DEHP, Musk xylene, SCCP, BBP and DBP are considered to have high priority for inclusion in Annex XIV because they fulfill indisputable one or more of the prioritisation criteria in REACH article 58(3). Because the production volume, the use and consequently the potential exposure will not result in significant risks for human or environment, the following substances are not fulfilling the criteria for prioritisation: anthracene, TBTO, cobalt dichloride, diarsenic pentaoxide, lead hydrogen arsenate and triethyl arsenate. For the three remaining substances, MDA, sodium dichromate and diarsenic trioxide, there are some doubts. Finally, NL concluded that MDA and sodium dichromate should be given priority for inclusion in Annex XIV. For diarsenic trioxide NL concluded that the substance is of low priority. More details are given at substance specific comments.	We thank you for your comment.

The prioritisation of the 7 selected substances for ECHA’s recommendation of candidate substances to be included in Annex XIV is the result of the application of a coherent priority setting approach, which has been presented to and discussed with the Member State Committee (MSC). Many members of the MSC expressed support to ECHA’s priority setting approach and in general it was positively received.
However, if there are elements in the prioritisation approach that are not supported, these may be discussed in forthcoming MSC meetings with the objective to further develop the approach so that it gets as broad as possible agreement.

As regards Netherlands (NL)’s disagreement with ECHA’s stance on the pertinence of subjecting substances to authorisation that could be easily replaced by other substances with the same/similar hazard profile: NL deem prioritisation of one of the substances in a group of substances with similar hazard potential to be a sufficient signal to industry that also these other compounds of the group are subject to the authorisation regime. We believe however that this view has no legal foundation in the REACH regulation since only substances whose ID is explicitly specified in an Annex XIV entry are subject to authorisation. Hence similar substances are not subject to this requirement, unless they are listed in Annex XIV. Prerequisite for inclusion of a substance in Annex XIV is the explicit identification as candidate substance. This requires specification of its identification and properties in an Annex XV dossier and a formal identification of its Substance of Very High Concern (SVHC) properties by the procedure laid down in Article 59 of REACH.	
20090330	MSCA, Norway	Norway supports the prioritisation of DBP for inclusion into Annex XIV. DBP is a HPV chemical that is formulated and prosessed at many sites and ends up in many products (preparations and articles) with a potential for exposure both for professionals and consumers. The end products are found widespread in the society. The prioritisation of DBP is therefore in accordance with article 58(3)(b) and (c).	We thank you for your support.	
20090402	Council of Europe, EDQM, France, regional or local authority (on behalf of)	Regulatory basis, as amended, for excluding uses of potential Annex XIV substances: Article 58(2) of the Regulation (EC) No 1907/2006 corr. The convention on the elaboration of the European Pharmacopoeia (European Treaty Series 50) and the protocol to the elaboration of the European Pharmacopoeia. Directive 2001/82/EC on the community code relating to veterinary medicinal products and Directive 2001/83/EC on the community code relating to medicinal products for human use. The paragraph 5.1 on exemptions under article 58(2) of REACH in general approach on justification for the draft annex XIV recommendation (14 January 2009) and, consequently, the article 2 of Directive 76/769/EEC.	See response given under “Substance specific comments related to prioritisation” section	
20090407	WWF (on behalf of CHEM Trust, Greenpeace, HEAL and WWF), Belgium, International NGO (on behalf of)	 CHEM Trust, Greenpeace, HEAL and WWF agree that in arriving at the overall conclusion on the priority of a substance, the ‘regulatory effectiveness’ of including the substance into the authorisation process should also be taken into account. The end goal is to protect humans and wildlife. Therefore one additional consideration in future prioritisations might be whether a chemical is known to exert additive effects with other chemicals to which humans and wildlife are known to be exposed. This is often the case for chemicals classified as toxic to reproduction (cat. 2), which have endocrine disrupting properties, such chemicals with known combined effects should in particular be considered for prioritisation for authorisation on the grounds that they may contribute to adverse effects on human health and the environment due to their effects or adverse outcomes being common to other chemicals affecting the same target tissue. 	We take note of the concerns raised regarding the potential additive or cumulative effects that may occur as a result of exposure of humans or the environment to different substances at the same time. The actual assessment of the magnitude of the potential risks that may occur though combined exposure is highly complex and needs substantial knowledge in terms of the exposure profile (which substances to take into account, at what level does the exposure occur and what is the spatial variability). In addition, in cases where the exposure profile would be known knowledge on the potential interactions that the different substances have in humans or environmental species needs to be known in order to be able to fully assess the potential effects of the combined exposure. 

Authorisations will be granted to specified actors (this can be manufacturers, importers or downstream users) who need to describe in their application the specific use or uses of the substance for which they request an authorisation. The Commission shall grant an authorisation if the risk to human health or the environment arising from the use of the substance is adequately controlled or, for substances falling under Article 60(3), may grant an authorisation if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. 

Taking into account this direct link between the actor, the use and the substance, it is difficult to envisage how in the decision-making process on an authorisation application for a specific substance the potential combined effects caused by exposure to other substances (which may or may not fall under the authorisation regime) can be taken into account. 

A potential exemption to the situation described above might be where the applicant makes use of the provisions provided for in Article 62(3) and submits an application dossier for a group of substances (fulfilling the requirements of section 1.5 of Annex XI). In cases where the applicant has based his grouping argumentation on a similar mode of (toxicological or ecotoxicological) action of the members of the group it could be expected that in the chemical safety assessment for this group the effects of potential combined exposure will also be addressed and therefore can be taken into account in the decision-making process. 	
20090408	MSCA, Ireland	IE would like to support the work that ECHA has done in prioritising and recommending the following 7 substances for inclusion in Annex XIV of the REACH Regulation. 
•	5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 
•	4,4’-Diaminodiphenylmethane (MDA) 
•	Alkanes, C10-13, chloro (SCCPs) 
•	Hexabromocyclododecane (HBCDD) (and all major diastereoisomers identified, i.e. α, β and γ-HBCDD) 
•	Bis(2-ethylhexyl) phthalate (DEHP) 
•	Benzyl butyl phthalate (BBP) 
•	Dibutyl phthalate (DBP)

Based on the information given in ECHA’s prioritisation and justification documents and following consultation with other relevant national authorities in Ireland, IE would have no objection to the inclusion of these 7 substances in Annex XIV.	We thank you for your support.	
20090409	MSCA, Austria	As Austria has submitted the dossier for this substance the Austrian CA supports the inclusion in Annex XIV with high priority.	We thank you for your support.	
20090409	MSCA, Poland	We support recommendation of Dibutyl phthalate (DBP) as a priority for inclusion in Annex XIV. We agree that DBP meets criteria ‘very high volumes’ and ‘wide dispersive use’ to its prioritisation for inclusion in Annex XIV.	We thank you for your support.	
20090414	MSCA, Czech Republic	We are concerned about the use of dibutyl phthalate in medicines and materials coming into direct contact with foodstuffs. In medicines dibutyl phthalate was used as an adjuvant, which in most cases was replaced by the adjuvant triethyl citrate, but it can still be found in certain proprietary medicinal products (Ranisan 150 mg, holder of registration decision Pro.Med.CS Praha a.s., Czech Republic, Convulex CR 300 and 500, holder Gerot Pharmazeutika GmbH, Austria, Asacol 800, holder Medimport spol. s.r.o., Czech Republic and Neuromax Forte, holder Vitabalans Oy, Finland). In 2006 the Danish Medicines Agency warned all member states of dibutyl pthalate (DBF) using the system of Rapid Alert in Pharmacovigilance (warning 6.10.2006). Two and a half years after the warning in the Rapid Alert system, a search in the database of proprietary medicinal products revealed DBF in the aforementioned cases. And so the measures concerning restriction of the content of DBF in medicines were insufficient. In materials coming into direct contact with foodstuffs Directive 2002/72/EC, as amended by Directive 2007/19/EC, permits the use of dibutyl phthalate, bis(2-ethylhexyl) phthalate and benzyl butyl phthalate (only with restriction for fat-free foodstuffs and with concentration restriction). We therefore call upon the European Chemical Agency to initiate in the frame of the European Commission a review of limitations concerning the content of phthalates in medicines and materials intended for direct contact with foodstuffs with the aim to ban or minimize the content of the substance in these materials. 	We thank you for your comments which will be sent to the European Commission as part of ECHA’s first recommendation on substances to be included in Annex XIV of the REACH Regulation.

However, we would like to clarify that reviewing the existing Community legislation is in the competence of the European Commission.	
20090414	Instituto Sindical de Trabajo, Ambiente y Salud (ISTAS), Spain, national NGO (on behalf of)	ETUC General comments: The prioritisation proposed by ECHA has been developed on the basis of the available information on intrinsic properties, uses, releases and volumes of the substances of very high concern on the Candidate List . According to article 58(3) priority for inclusion in Annex XIV shall normally be given to substances with: a) PBT or vPvB properties; or b) wide dispersive use; or c) high volumes. ECHA states that: “Given that the listing of the criteria is connected by the term ‘or’, this means that meeting one criterion could in principle be sufficient to prioritise a substance for inclusion in Annex XIV. However, in order to allow further differentiation the approach actually followed for prioritising the candidate substances for inclusion in Annex XIV also considers how many of these three criteria are met by the candidate substance concerned and to what degree”. However, in ETUC's opinion ECHA has not followed a clear and comprehensive methodology for prioritizing substances and the justification that has been given in some cases is not in accordance with the announced criteria. For example, ECHA has justified not to prioritize several substances due to the lack of information on releases (sodium dichromate, cobalt dichloride, diarsenic pentaoxide) or to the lack of information on safer alternatives (cobalt dichloride, diarsenic pentaoxide, diarsenic trioxide and sodium dichromate). These reasons for non prioritization are also not in accordance with the Precautionary Principle stated in the REACH recital (69): “To ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention.” In ETUC's view, complete information on alternatives and releases shall be generated by the company asking for authorization for a certain use, and should not be a criteria for not including a SVHC in the Authorization list. In addition, we consider that the Prioritization criteria used by ECHA do not take into account workers health when considering human exposure. Only consumer exposure has been considered and used as justification not to prioritize several HPV substances (triethyl arsenate, anthracene, diarsenic pentaoxide, diarsenic trioxide, sodium dichromate and lead hydrogen arsenate). However, these susbstances are of high importance for workers health and are known to cause recognized work-related diseases at Community level (Commission Recommendation of 19 September 2003 concerning the European schedule of occupational diseases (notified under document number C(2003) 3297) (Text with EEA relevance) (2003/670/EC) ANNEX I). In order to better take into consideration worker's health and given that in Article 58(3) the term "normally" implies that the criteria mentioned do not need to be seen as exclusive, ETUC suggests that ECHA should take into account an additional criterion for prioritising SVHC in the Annex XIV. This criterion should be the existence of recognised occupational diseases linked to the SVHCs. ETUC has recently proposed a methodology to prioritise SVHC taking into account this specific criterion (see attached document). The Trade Union Priority List for REACH Authorisation includes 306 HPVC entries also ordered by score by reference to their intinsic eco-toxicological properties. We believe that if those chemicals are included in the candidate list and subsequently prioritised in the Annex XIV, it would surely promote the development of safer alternatives and cut both the incidence of chemical-related occupational diseases and the attendant costs for the Community, workers and industry itself.
+ see attachment	We thank you for your comment.

However, we do not agree with the statement that in developing/applying ECHA’s prioritisation approach the precautionary principle and/or worker’s health were not taken into consideration. From the published description of the prioritisation approach (‘General Approach for Prioritisation of Substances of Very High Concern for Inclusion in the List of Substances Subject to Authorisation’, one of the documents used by ECHA for preparation of its Recommendation) it should be concluded that information on occupational health has been taken into account.

It further seems to be a misunderstanding of ECHA’s explanations regarding the priority of particular candidate substances to claim that ECHA had justified not to prioritise several substances with lack of information on releases (sodium dichromate, cobalt dichloride, diarsenic pentaoxide) or with lack of information on safer alternatives (cobalt dichloride, diarsenic pentaoxide, diarsenic trioxide and sodium dichromate), and by doing so had violated the precautionary principle. Decisive factor for non-prioritisation of all above mentioned metal salts and oxides was not uncertainty about exposure or alternatives but the possibility that these substances could be easily replaced by other salts or forms of the metal with the same or a similar hazard potential, which would render any authorisation measures imposed solely on the mentioned substances ineffective unless the closely related compounds could as well be subjected to the authorisation requirement in a grouping approach. This requires however first the development of Annex XV dossiers for the similar metal compounds and their identification as SVHC in accordance with Article 57.

As far as your proposal on consideration of further prioritisation criteria and the supplementary information on ETUC’s prioritisation are concerned, these will be taken into account in the further development of the prioritisation approach developed by ECHA.	

Substance specific comments related to prioritisation
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090211	Germany, academic institution (affiliated with)	p19 f; End product uses: DBP is used in gastric juice resistant coatings of capsules and tablets. This is of relevanve for (registered) medications, but also prescription free medications, may be of relevance for food supplements or vitamine/enzyme preparations. The content in one capsule can be up to 20mg, and several capsules can be swallowed each day (e.g. etheric oil capsules). This sums up to possible daily exposures of 50-100mg/absolute/day. Users may be pregnant. DBP containing medications (as a [product A]) in Germany are listed in the "Rote Liste". In the publication attached we have calculated (by means of human biomonitoring) the DBP content of one capsule of [product B], which is a prescription free capsule containing etheric oil, to be 8.6mg each. Biomonitoring proved that this amount was sytemically resorbed by the body. DBP is also used in dental restorative materials and tissue conditioners (e.g. [products C, D and F]) used in dentistry. This most likely also also cumulates in non negligible DBP exposures. 
+ see attachment	We thank you for your comment.

However, we would like to clarify that, according to Art. 2(5) of the REACH Regulation, the provisions of the authorisation title do not apply to substances used “in medicinal products for human or veterinary use within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC […] and Directive 2001/83/EC…”.
In case the uses of DBP you refer to fall under the definition of uses of a substance in a medicinal product, as defined by Directive 2001/83/EC, the authorisation requirement under the REACH Regulation does not apply to these uses.	
20090217	MSCA, Luxembourg	We support the prioritisation of DBP for inclusion in Annex XIV	We thank you for your support.	
20090313	Germany, company (on behalf of)	Document reference: http://echa.europa.eu/doc/consultations/recommendations/justifications/justif_dbp.pdf, page 4, section "5.Proposed exempted categories of uses".
Proposal: To exempt from the authorisation requirement the placing on the market of DBP in a preparation for the supply to industrial users for the use as analytical standard for test and measurement instruments. Our company does currently not have industry data with respect to volumes or concentrations of DBP used in analytical standards, but is committed to provide a constant stream of new measurement solutions to the environmental measurement market place.	See response given under “General comments on the prioritisation” section	
20090324	MSCA, The Netherlands	DBP NL agrees with ECHA’s opinion to prioritize this substance, in our ranking the substance scored high priority (10). 1) no PBT/vPvB (score 0) 2) DBP is produced in high volumes, volumes for all relevant life cycle stages are between 1,000 and 10,0000 t/y (volume: score 4 – high) 3) many applications and widespread use all over EU (use: score 3 – widespread) 4) there is a high potential for release, both for professionals and consumers (release: score 3 - diffuse/ uncontrolled/ significant)	We thank you for your support and additional information.	
20090330	MSCA, Norway	Document on "Prioritisation and Annex XIV background information", chapter 7, page 6 and 7, (including table 4); DIBP is listed as an alterative to DBP for several applications. However, DIBP (CAS no. 84-69-5) is classified according to the 31st ATP (Commission Directive 2009/2/EC amending Council Directive 67/548/EEC) as Repr. Cat 2; R 61 and Repr. Cat. 3; R62. Therefore DIBP, as well as DBP, meets the criteria in Article 57(c) and DIBP should not be listed as a possible alternative.	We thank you for this further information which will be taken into account together with any other contributions when preparing the final recommendation and its supporting documents to be sent to the European Commission by 1 June 2009.
	
20090402	Council of Europe, EDQM, France, regional or local authority (on behalf of)	An article 58(2) exemption to annex XIV of Regulation (EC) No 1907/2006 corr is requested for the use of Dibutyl phthalate (DBP) for analytical purposes as prescribed in the European Pharmacopoeia, including use as a reference standard or as a reagent. Exemption for use in the International Pharmacopoeia of the World Health Organisation, when applicable, is also requested. Although analytical uses of the substance are carried out under controlled conditions with small quantities, the European Pharmacopoeia is continuously seeking for alternatives to substances of very high concern. The exemption is requested to prevent disruption in the supply of medicinal products in the EU market or in exportation of medicinal products from the EU to third countries.	We thank you for your comment.

We would like to clarify that, according to Art. 56(3) of the REACH Regulation, the obligations of Art. 56(1) and 56(2) “shall not apply to the use of substances in scientific research and development”.
Hence, as defined in Art. 3(23) of REACH the placing on the market of a substance for any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year does not require authorisation.
ECHA is of the opinion that, provided that the use of the substance is actually in accordance with the definition of “scientific research and development” under REACH, and in particular fulfils its specific conditions, the placing on the market for this specific use does not require an authorisation.	
20090409	European Council for Plasticisers and Intermediates, Belgium, industry or trade association (on behalf of)	See attachment	We thank you for this further information which will be taken into account together with any other contributions when preparing the final recommendation and its supporting documents to be sent to the European Commission by 1 June 2009.

However, please note that the technical report on “Data on Manufacture, import, Export, Uses and Releases of as well as information on potential alternatives to its use” will not be updated.	
20090414	Allgemeine Unfallversicherungsanstalt, Austria, national authority (on behalf of)	p27 technical report “Working Environment” In the Risk Assessment Report (on which the technical report explicitly is based on) one can find estimated exposures based on EASE: “- internal mixer: closed system, breached (= non dispersive use) and LEV: 0.5-3 ppm (ca. 6 to 35 mg/m3), this procedure may be performed full shift; - open mill mixing; non-dispersive use with direct handling and dilution ventilation: 10 to 50 ppm (110 to 580 mg/m3) or non-dispersive use and LEV: 0.5-3 ppm (6 to 35 mg/m3); it is assumed that the scenario is relevant for 2 hours a day; the eight hour time-weighted average value then becomes 27.5-145 mg/m3 or 1.5-8.8 mg/m3; … - forming steps; non-dispersive use and LEV: 0.5-3 ppm (ca. 6 to 35 mg/m3); this activity can be performed full shift.” (European Risk Assessment Report, Dibutyl Phtalate, Addendum to the Environmental Section – 2004, 52) In other words: The EU Risk Assessment Report estimates a work place exposure (inhalation) up to the 29-fold of the OEL !! Having in mind the measured values in a controlled working environment presented in the RAR authorisation is the suitable instrument of regulating the use of DBP. On the other hand the results of some concentration measurements performed in practice show that airborne concentrations can be kept rather low. This points out the need of tough regulations. 	We thank you for your support and additional information.	
20090414	MSCA, Sweden	We support the prioritisation of DBP for inclusion in Annex XIV. The substance fulfils two of the criteria for prioritisation mentioned in REACH Art. 58.3 –wide dispersive use and high volume.	We thank you for your support.	
20090414	Instituto Sindical de Trabajo, Ambiente y Salud (ISTAS), Spain, national NGO (on behalf of)	The ISTAS do agree with the prioritisation stated by ECHA for this substance.
+ see attachment	We thank you for your support.	

II - comments and responses to comments on the draft Annex XIV entries 

General comments on the justification
Date 	Submitted by (name, Organisation/MSCA)	Comment	Response	
20090330	MSCA, Norway	Norway supports the prioritisation of DBP for inclusion into Annex XIV. DBP is a HPV chemical that is formulated and prosessed at many sites and ends up in many products (preparations and articles) with a potential for exposure both for professionals and consumers. The end products are found widespread in the society. The prioritisation of DBP is therefore in accordance with article 58(3)(b) and (c). 	We thank you for your support.	
20090402	Council of Europe, EDQM, France, regional or local authority (on behalf of)	Regulatory basis, as amended, for excluding uses of potential Annex XIV substances: Article 58(2) of the Regulation (EC) No 1907/2006 corr. The convention on the elaboration of the European Pharmacopoeia (European Treaty Series 50) and the protocol to the elaboration of the European Pharmacopoeia. Directive 2001/82/EC of the European Parliament and of the Council on the community code relating to veterinary medicinal products and Directive 2001/83/EC of the European Parliament and of the Council on the community code relating to medicinal products for human use. The paragraph 5.1 on exemptions under article 58(2) of REACH in general approach on justification for the draft annex XIV recommendation (14 January 2009) and, consequently, the article 2 of Directive 76/769/EEC.	See response given under “Substance specific comments related to prioritisation” section	
20090406	MSCA, United Kingdom	The UK REACH CA sent in comments by the end of February, as requested by the MSC secretariat. Within the UK there has also been consultation across all relevant governments departments and devolved administrations within the UK. As a result, some additional comments have been collected. These are indicated below – along with repeating the earlier comments from the CA, so as to keep everything together. The additional comments do not change the previous “UK” position on DBP.		
20090407	WWF (on behalf of CHEM Trust, Greenpeace, HEAL and WWF), Belgium, International NGO (on behalf of)	CHEM Trust, Greenpeace, HEAL and WWF support the prioritisation for inclusion in Annex XIV due to the very high volumes and wide dispersive uses. We do not agree with the suggested route for authorisation, i.e. that this phthalate should be authorised via the adequate control of the risk route. There is now incontrovertible evidence that DBP, DEHP and BBP can act additively, and moreover, can contribute to effects in animals even when each is below its 'effect' concentration (see 2008 report by the US National Academy of Sciences http://www.nap.edu/catalog.php?record_id=12528#toc). In addition, there is known widespread exposure to phthalates and other substances that act as anti-androgens. Therefore, we believe that it should be deemed under Annex 1, 1.4.2 and 3.3.2 of the REACH regulation that due to the combined effects it is not possible to identify a DNEL or derive a PNEC, and thus it is not possible to determine a threshold which will be protective. In order to protect humans and wildlife, authorisation should only be granted if the socio-economic benefits outweigh the risk and there are no suitable alternatives. For more details please see attached NGO briefing with detailed scientific references. 
+ see attachment	We take note of the concerns raised regarding the potential additive or cumulative effects that may occur as a result of exposure of humans or the environment to different substances at the same time. The actual assessment of the magnitude of the potential risks that may occur though combined exposure is highly complex and needs substantial knowledge in terms of the exposure profile (which substances to take into account, at what level does the exposure occur and what is the spatial variability). In addition, in cases where the exposure profile would be known knowledge on the potential interactions that the different substances have in humans or environmental species needs to be known in order to be able to fully assess the potential effects of the combined exposure. 

Authorisations will be granted to specified actors (this can be manufacturers, importers or downstream users) who need to describe in their application the specific use or uses of the substance for which they request an authorisation. The Commission shall grant an authorisation if the risk to human health or the environment arising from the use of the substance is adequately controlled or, for substances falling under Article 60(3), may grant an authorisation if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. 

Taking into account this direct link between the actor, the use and the substance, it is difficult to envisage how in the decision-making process on an authorisation application for a specific substance the potential combined effects caused by exposure to other substances (which may or may not fall under the authorisation regime) can be taken into account. 

A potential exemption to the situation described above might be where the applicant makes use of the provisions provided for in Article 62(3) and submits an application dossier for a group of substances (fulfilling the requirements of section 1.5 of Annex XI). In cases where the applicant has based his grouping argumentation on a similar mode of (toxicological or ecotoxicological) action of the members of the group it could be expected that in the chemical safety assessment for this group the effects of potential combined exposure will also be addressed and therefore can be taken into account in the decision-making process.	
20090408	Finnish Defence Forces (FDF), Finland, national authority (on behalf of)	FDF supports the inclusion of DBP on the authorisation list due to its health risks when used in products made available to the general public. Nevertheless, the use of DBP in military propellants, and their use in military propelling charges should be exempted from the authorisation requirements, due to the special constraints pertaining to the defence of the nation. This exemption for DBP, and mixtures, should include manufacture, storage, transport, use in manufacturing of propellants, use of such propellants in the production of propelling charges, use and disposal of the said propellants and charges. 	We thank you for your comment.

Article 58(2) of the REACH Regulation provides that “Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled….”

Accordingly, in light of this provision and the guidance on inclusion of substances in Annex XIV, in order to exempt a use of a substance to be included in Annex XIV the following elements should be considered:

•	There is existing Community legislation addressing the use (or categories of use) that is proposed to be exempted. Special attention has to be paid to the definition of use in the legislation in question compared to the REACH definitions. Furthermore, the reasons for and effect of any exemptions from the requirements set out in the legislation have to be assessed;
•	This Community legislation properly controls the risks to human health and/or the environment from the use of the substance arising from the intrinsic properties of the substance that are specified in Annex XIV; generally, the use in question should also specifically refer to the substance to be included in Annex XIV either by naming the substance specifically or by referring to the group the substance belongs to e.g. by referring to the classification criteria or the Annex XIII criteria;
•	This Community legislation imposes minimum requirements for the control of risks of the use. Firstly, ‘the minimum requirements’ entails that the Member States may adopt more stringent but not less stringent requirements when implementing the specific Community legislation in question. Secondly, the piece of legislation has to define the measures to be implemented by the actors and to be enforced by authorities in a way that ensures the similar minimum level of control of risks throughout the EU and that this level can be regarded as proper. Legislation setting only the aim of measures or leaving the actual type and effectiveness of measures required ambiguous is not enough. Furthermore, attention should be paid on whether and how the risks related to the life-cycle stages resulting from the uses in question (i.e. service-life of articles and waste stage(s) as relevant) are covered.

From ECHA’s assessment of the available information, there appears to be no Community legislation regulating the use of DBP in military propellants.

Therefore, on the basis of the available information, ECHA does not see grounds for proposing a general exemption for uses of DBP in military propellants in accordance with Art. 58(2) of REACH.

However, we would like to mention that, according to Art. 2(3) of REACH, Member States may allow for exemptions from REACH Regulation in specific cases for certain substances, on their own, in a preparation or in an article, where necessary in the interests of defence.
Therefore, ECHA would recommend you to refer to your national authorities in order to request such a specific exemption.	
20090408	MSCA, Ireland	We can support the proposed transitional arrangements, proposed review periods for certain uses (where applicable) and the proposed exempted (categories of) uses (where applicable).	We thank you for your support.	
20090409	MSCA, Austria	As Austria has submitted the dossier for this substance the Austrian CA supports the inclusion in Annex XIV with high priority.	We thank you for your support.	
20090409	MSCA, Germany	The German CA supports the justification document. DBP clearly fulfills the criteria of REACH article 58(3)to be recommended with priority for inclusion in Annex XIV.	We thank you for your support.	
20090413	Federal Ministry of Trade and Industry, Egypt, national authority (on behalf of)	No comment
		
20090414	Emerson Process Management – Rosemount Nuclear Instruments, United States, company (on behalf of)	[The company] supplies pressure transmitters specially designed for nuclear installations. RNII is wholly owned subsidiary of [the company] believes that the justification does not take sufficiently into account the specific constraints related to the nuclear power industry. Dibutyl phtalate is one of the substances used in the design and manufacture of the pressure transmitters specially designed for use in safety shutdown and the harsh environments in the nuclear power industry. Dibutyl phtalate is used in a 2 part epoxy compound, which serves as a barrier within the transmitter to prevent moisture from migrating into the transmitter’s electronics, from the outside environment. This barrier is critical to the transmitter’s reliability. Should this barrier fail, the safety function of the product could be compromised. There are a small number of instrument producers providing industrial process instrumentation for safety applications to this industry. [The company]’s instrument designs have been used for many years in the nuclear power industry and have a proven history for reliable and consistent operation. This segment of the energy industry is expected to grow in the years ahead due to various factors, including climate change pressures and a growing need for alternative energy sources. Though not specifically spelled out as an authorised use, such as the use of DBP in artists’ paints under Directive 1999/45/EC, the use of dibutyl phthalate in pressure transmitters for nuclear power installations is already permitted under the current Committee legislation, i.e. Directive 76/769/EC and Annex XVII of REACH. Moreover, as it will be developed in our following comments, given the constraints to the qualification process of substitutes in the nuclear industry, the very low quantity of dibutyl phthalate used, the low to absence of risk to those who handle the instrument or to the environment and the critical role of pressure transmitters for nuclear safety, [the company] believes an exemption of this use of DBP is justified under Article 58.2 of REACH, rather than requesting an authorised use at a later date. 	We thank you for your comment.

However, we would like to clarify that, according to Article 58(2) of the REACH Regulation, “Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled….”

Accordingly, in light of this provision and the guidance on inclusion of substances in Annex XIV, in order to exempt a use of a substance to be included in Annex XIV the following elements should be considered:

•	There is existing Community legislation addressing the use (or categories of use) that is proposed to be exempted. Special attention has to be paid to the definition of use in the legislation in question compared to the REACH definitions. Furthermore, the reasons for and effect of any exemptions from the requirements set out in the legislation have to be assessed;
•	This Community legislation properly controls the risks to human health and/or the environment from the use of the substance arising from the intrinsic properties of the substance that are specified in Annex XIV; generally, the use in question should also specifically refer to the substance to be included in Annex XIV either by naming the substance specifically or by referring to the group the substance belongs to e.g. by referring to the classification criteria or the Annex XIII criteria;
•	This Community legislation imposes minimum requirements for the control of risks of the use. Firstly, ‘the minimum requirements’ entails that the Member States may adopt more stringent but not less stringent requirements when implementing the specific Community legislation in question. Secondly, the piece of legislation has to define the measures to be implemented by the actors and to be enforced by authorities in a way that ensures the similar minimum level of control of risks throughout the EU and that this level can be regarded as proper. Legislation setting only the aim of measures or leaving the actual type and effectiveness of measures required ambiguous is not enough. Furthermore, attention should be paid on whether and how the risks related to the life-cycle stages resulting from the uses in question (i.e. service-life of articles and waste stage(s) as relevant) are covered.

As the specific use of DBP in equipments for nuclear installations is not currently restricted or explicitly exempted from a restriction under Directive 76/769/EC and Annex XVII of REACH, it cannot be considered that that use of DBP is addressed by that specific Community legislation.

From ECHA’s assessment of the available information, there appears to be no Community legislation regulating the use of DBP in equipments for nuclear installations. Therefore, on the basis of the available information, ECHA does not see grounds for proposing for that use an exemption in accordance with Art. 58(2) of REACH. ECHA will however in its recommendation suggest to the Commission to verify this point.

Furthermore, we would like to stress that the information on both the low level of risks and the availability and suitability of alternatives cannot be taken into account in defining whether this use warrants an exemption as there is no connection to existing specific Community legislation.
This information, however, may be part of the applications for authorisation to be submitted to ECHA (Art. 62(4) (d) – Chemical Safety Report and (e) – analysis of alternatives), and will be taken into account when the Agency needs to develop its opinions on any application and the European Commission takes a decision on whether to grant an authorisation and what type of conditions and how long review period such an authorisation will include.	
20090414	Individual, United Kingdom	[n.b.: For all the comments I submitted on nine of the chemicals up for Authorization, my citations to the literature, though without DOIs or titles, can be easily found by entering the author/s last name/s followed by the initial/s into PubMed’s search box at http://www.ncbi.nlm.nih.gov/pubmed/ (using the rest of the citation to find the paper’s abstract amongst the chronologically-sorted search results).] Since the US NRC reviewed the P.E. toxicity literature, concluding that it indicates this risk should be assessed cumulatively, data has continued to be published (including that presented below) that mammalian exposure to real-world mixed P.E. disrupt the development of the male reproductive tract at doses lower than the doses previously determined to be safe…P.E. by P.E. Therefore you can never prove that each of these three PE can be “adequately controlled”; i.e. asking ‘what is one P.E.’s safe dose?’ does not inform risk. DBP’s sexual differentiation disruption in controlled experiments occurred within five-fold of the body burden of a significant minority of humans…but even this safety margin for one PE is “destroyed” by the findings of the same effects by five or seven P.E. together at “safe” doses (see the comment: Sharpe RM 2008 Toxicol. Sciences:105(1)1-4). Obviously, you must instead use other provisions to achieve your REACh mandates to protect us. P.E.’s disruption of sexual differentiation are already are known to have many differences: agent, timing, species, and upstream effect distinctions (just now being discovered--see the work of Dr. Sharpe). However the same laboratory and work by Dr. A. Kortenkamp have shown that other anti-androgens, including pesticides and pharmaceuticals, which also have differences; nevertheless lead to the same endpoint. So any disruptor of a toxic endpoint, no matter its mode of action (e.g that inhibit testosterone (T) and insl-3, key precursors to the male reproduction disruption, by P.E.), should be considered in risk assessment. Mammalian sexual differentiation in many details is highly conserved including humans, including the key T and insl-3 that are inhibited by P.E. (see a review of the above cumulative lo-dose P.E. findings: Howdeshell KL et al. 2008 Environ Res.:108(2):168-76). That humans are thus vulnerable to the same cumulative lo-dose P.E. toxic endpoints found in animals also is supported by actual human findings (though only correlations)—i.e actual, even common human mother’s P.E. body burdens are associated in a dose/response manner with some of these markers of male reproductive disorder (for a discussion of this first-ever finding, see the accompanying editorial, Sharpe RM. 2005 Environ Health Perspect:113:8:A504-5). Again showing that you cannot assume that species differences will protect humans: not only is DEHP’s peroxisome proliferation route to cancer (and other toxicity) applicable to humans, contrary to the usual refrain of the chemical industry (Melnick RL 2001 Environ Health Perspct:109:5:437-42); but it has been revealed that industry influence played a role in suppressing that important data when IARC evaluated DEHP’s carcinogenicity (Melnick R.L. 2003 Intl J Occup & Environmental Health:9:1:84-5 (correspondence) and Mirer F.F. (correspondence) 2003 Intl J Occup & Environmental Health:9:1:85-7). Note the medical industry, populating and so influencing IARC cancer evaluation panels, is a big user of DEHP! Nor can you ignore P.E. effects on the brain’s sexual differentiation—which involves many of the same proteins as develop the reproductive tract. Are you aware that this experimental literature includes sexual brain toxicity at the general human population burdens of DEHP (Andrade AJ, et al. 2006 Toxicology:227(3):185-92)? In summary for P.E.: cumulative, actual human body burden (low dose), developmental-age risk assessment (such as the repressed US EPA dioxin risk assessment) are needed if you are to fulfill your REACh mandates. As to the Authorization of P.E., the property of plasticity is obviously ubiquitous among the infinite number of organic and other chemicals--you already have much information of available alternative plasticizers. The above indications of risk from real-world levels of real-world mixtures of PE is cause for both better risk assessment and more rapid phase-out of the riskiest situations. Please note that while the European work of Dr. Kortenkamp et al., finding such dose-additive toxicity (each dose below it’s (alleged) safe dose for some anti-androgens but not P.E.; and the findings of Dr. Sharpe do not test cumulative P.E. exposure; the dose-additive results of Dr. Earl Gray Jr. are PE mixes. --	We take note of the concerns raised regarding the potential additive or cumulative effects that may occur as a result of exposure of humans or the environment to different substances at the same time. The actual assessment of the magnitude of the potential risks that may occur through combined exposure is highly complex and needs substantial knowledge in terms of the exposure profile (which substances to take into account, at what level does the exposure occur and what is the spatial variability). In addition, in cases where the exposure profile would be known knowledge on the potential interactions that the different substances have in humans or environmental species needs to be known in order to be able to fully assess the potential effects of the combined exposure. 

Authorisations will be granted to specified actors (this can be manufacturers, importers or downstream users) who need to describe in their application the specific use or uses of the substance for which they request an authorisation. The Commission shall grant an authorisation if the risk to human health or the environment arising from the use of the substance is adequately controlled or, for substances falling under Article 60(3), may grant an authorisation if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. 

Taking into account this direct link between the actor, the use and the substance, it is difficult to envisage how in the decision-making process on an authorisation application for a specific substance the potential combined effects caused by exposure to other substances (which may or may not fall under the authorisation regime) can be taken into account. 

A potential exemption to the situation described above might be where the applicant makes use of the provisions provided for in Article 62(3) and submits an application dossier for a group of substances (fulfilling the requirements of section 1.5 of Annex XI). In cases where the applicant has based his grouping argumentation on a similar mode of (toxicological or ecotoxicological) action of the members of the group it could be expected that in the chemical safety assessment for this group the effects of potential combined exposure will also be addressed and therefore can be taken into account in the decision-making process.	
20090414	MSCA, Czech Republic	We are concerned about the use of dibutyl phthalate in medicines and materials coming into direct contact with foodstuffs. In medicines dibutyl phthalate was used as an adjuvant, which in most cases was replaced by the adjuvant triethyl citrate, but it can still be found in certain proprietary medicinal products (Ranisan 150 mg, holder of registration decision Pro.Med.CS Praha a.s., Czech Republic, Convulex CR 300 and 500, holder Gerot Pharmazeutika GmbH, Austria, Asacol 800, holder Medimport spol. s.r.o., Czech Republic and Neuromax Forte, holder Vitabalans Oy, Finland). In 2006 the Danish Medicines Agency warned all member states of dibutyl pthalate (DBF) using the system of Rapid Alert in Pharmacovigilance (warning 6.10.2006). Two and a half years after the warning in the Rapid Alert system, a search in the database of proprietary medicinal products revealed DBF in the aforementioned cases. And so the measures concerning restriction of the content of DBF in medicines were insufficient. In materials coming into direct contact with foodstuffs Directive 2002/72/EC, as amended by Directive 2007/19/EC, permits the use of dibutyl phthalate, bis(2-ethylhexyl) phthalate and benzyl butyl phthalate (only with restriction for fat-free foodstuffs and with concentration restriction). We therefore call upon the European Chemical Agency to initiate in the frame of the European Commission a review of limitations concerning the content of phthalates in medicines and materials intended for direct contact with foodstuffs with the aim to ban or minimize the content of the substance in these materials.	See response given under “General comments on the prioritisation” section	
20090414	Allgemeine Unfallversicherungsanstalt, Austria, national authority (on behalf of)	The prioritisation is strongly supported, in particular from the viewpoint of occupational health.
	We thank you for your support.	
20090414	Huntsman (Europe) BVBA, Belgium, company (on behalf of)	For correct formatting the comments submitted also as pdf. We propose that the use of dibutyl phthalate (DBP) as an absorption oil in the purification of maleic anhydride (MAN) is exempted from the authorisation requirement. [The company] is a global manufacturer and marketer of differentiated chemicals. Its operating companies manufacture products for a variety of global industries, including chemicals, plastics, automotive, aviation, textiles, footwear, paints and coatings, construction, technology, agriculture, health care, detergent, personal care, furniture, appliances and packaging. [The company] is the world’s largest producer of maleic anhydride and a leading licensor of technology for its production. [The company] is also a worldwide supplier of catalyst required in the production of maleic anhydride. [The company] today has 13,000 employees and operates from multiple locations worldwide, including major administrative and research centers in Everberg, Belgium and Basel, Switzerland and more than 20 manufacturing locations throughout the EU. [The company] had 2008 revenues of approximately $10 billion. [The company] has successfully pre-registered 1,937 chemical substances that [the company] manufactures or imports into the European Economic Area, as required by the European Community REACH legislation. For more information please go to our website at [the company’s website]. Sasol-Huntsman is a 50/50 joint venture between Huntsman and Sasol, founded in 1997 by Huntsman Corporation and RWE-DEA Aktiengesellschaft fuer Mineraloel und Chemie (Condea). Sasol took over the shares of Condea Chemie GmbH during the acquisition of the Condea Chemie business in 2001. Both Sasol and Huntsman have retained equal shares in the joint venture. The joint venture produces and markets maleic anhydride in Central and Western Europe, Scandinavia, East Europe, on the Iberian peninsula, in Turkey and in Northern Africa. For more information please go to our website at [the company’s website]. We do not disagree with the information provided in “Justification for the Draft Recommendation of Inclusion [of DBP] in Annex XIV,” 14 January 2009 (Justification), the ECHA “Prioritisation and Annex XIV Background Information,” 14 January 2009 (Background) and “Data on Manufacture, Import, Export, Uses, Releases of DBP as Well as Information on Potential Alternatives to its Use,” 29 January 2009 (Technical). But in our view the documents completely fail to address the use of DBP as an absorption oil in the manufacture of MAN, which we now bring to your attention. Justification, page 2: “DBP is either processed - mainly as gelling aid and plasticiser - in various types of polymers (PVC and other polymers) or formulated as component in preparations (e.g. adhesives, grouting agents, paints). These different applications and relatively high amounts of DBP used may indicate that a large number of companies are involved in the further processing and formulation of DBP down into the supply-chains. A wide range of end-products containing DBP are produced and used by potentially high number of users. Furthermore, users of the end products containing DBP represent several different industry sectors and professional user groups.”  While this is correct, this does not address the use of DBP as an absorption oil in the production of MAN.  At the MAN plant, in the closed process, DBP is used under strictly controlled conditions.  The DBP content of the MAN product is less than 10ppm.  There is no further processing or formulation of DBP in the use of MAN in the downstream supply chain.  Outside the plant, as DBP is present only in trace amounts in the finished MAN product, the potential exposure of humans or the environment is minimal. Background, page 4: “It is worthwhile noticing that DBP when used as a plasticiser is not chemically bound in the matrix.”  While this is correct, this does not address use of DBP as an absorption oil in the production of MAN.  The DBP content of the MAN product is less than 10ppm. Background, page 5: “No information is available on releases to the working environment. In the RAR (EC,2004) it was concluded that a worst case for exposure via inhalation is estimated at 5mg/m3 (aerosol) based on measurements, and for dermal exposure to be at 650 mg/day on a skin area of 1,300 cm2 based on the EASE model. The highest concentrations in the indoor environment are expected in rooms with DBP plasticised floorings, because of the large surfaces from where the substance can be released (Lassen et al., 2009). The estimated releases to the environment from all activities are summarised in Table 3. The emission factors applied in this study are largely derived from the EU Risk Assessment Report for DBP (EC, 2004). The main releases are to air and waste water. The use of end products gives rise to the largest releases to the environment. The releases from landfill may in fact be higher than indicated if total releases until the DBP is ultimately degraded are considered, but no data on the long term fate of DBP in landfills have been made available.”  While this is correct when DBP is used as a plasticiser, this does not address use of DBP as an absorption oil in the production of MAN.  At the MAN plant, in the closed process, DBP is used under strictly controlled conditions.  At the MAN plant, DBP is handled by qualified, trained employees in accordance with 98/24/EC.  At the MAN plant, DBP potential emissions are controlled in accordance with 96/61/EC.  All waste streams of DBP are incinerated under continuous emissions monitor (CEMs), on-line control to the governmental agency.  The emissions of DBP to the air from the MAN plant are less than 250 grams per year. Background, page 6: “The formulation and processing of DBP into preparations and into polymer products by major users take place at 50-100 sites in the EU. The end products are widely used in the EU. As DBP is not chemically bound in either preparations or articles, the potential for release and subsequent exposure is high. Consequently, there is a wide dispersive use of preparations and articles containing DBP.”  While this is true when DBP is used in preparations and polymer products, this does not address use of DBP as an absorption oil in the production of MAN.  The DBP content of the MAN product is less than 10ppm.  Outside the MAN plant, as DBP is present only in adventitious, trace amounts in the finished MAN product, the potential exposure of humans or the environment is minimal. Technical, page 13: heading “Information on uses and releases from uses”  Use of DBP as an absorption oil is not an identified use under this section. Technical, page 21: heading “Formulation and processing”  This discussion is not relevant for use of DBP as an absorption oil. Technical, page 23: heading “End product uses”  This discussion is not relevant for use of DBP as an absorption oil. Technical, page 27: headings “Working environment” and “Loss of waste from downstream polymer article production”  The occupational exposures and DBP-contaminated wastes issues addressed here are not relevant for use of DBP as an absorption oil in the production of MAN.  At the MAN plant, in the closed process, DBP is used under strictly controlled conditions.  At the MAN plant, DBP is handled by qualified, trained employees in accordance with 98/24/EC.  At the MAN plant, DBP potential emissions are controlled in accordance with 96/61/EC.  All waste streams of DBP are incinerated under on-line control by authorities.  The emissions of DBP to the air from the MAN plant are less than 250 grams per year.  Outside the MAN plant, as DBP is present only in trace amounts in the finished MAN product, the potential exposure of humans or the environment is minimal. Technical, pages 28-29: headings “Non-PVC formulation and processing” and “End-product uses”  The further processing and use of products containing DBP and the issues presented is not relevant for use of DBP as an absorption oil in the manufacture of MAN.  All waste streams of DBP are incinerated using CEMs, on-line control with the authorities.  The emissions of DBP to the air from the MAN plant are less than 250 grams per year. Technical, pages 31-33: heading “Quantification of releases from waste disposal”  The issues regarding solid waste incineration at municipal incinerators, landfill disposal, bio-treatment, and waste water disposal issues do not occur in the use of DPB as an absorption oil in MAN manufacturing.  At the MAN plant, DBP potential emissions are controlled in accordance with 96/61/EC.  All waste streams of DBP both on-site and for waste materials sent off-site are incinerated using CEMs, on-line control with the authorities.  The emissions of DBP to the air from the MAN plant are less than 250 grams per year. Technical, page 34: heading “Information on alternatives”  While the offered alternatives are relevant when DBP is used as a plasticiser, this section does not provide any technically feasible alternatives to the use of DBP as an absorption oil in the production of MAN.

+ See attachment	Thank you for your comments and further information on uses of DBP. 
This information will be taken into account together with any other contributions when preparing the final recommendation and its supporting documents to be sent to the European Commission by 1 June 2009.
However, we would like to clarify that the different background and justification papers developed for or by ECHA do not cover all uses of the substances but focus on the available knowledge on the main uses of the substance. It is important to note that the substance-specific entries in this first recommendation are nevertheless not use-specific but address all uses of the substance subject to authorisation requirement.

As far as your request for an exemption from authorisation requirement under REACH is concerned, Article 58(2) provides that “Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled….”

Accordingly, in light of this provision and the guidance on inclusion of substances in Annex XIV, in order to exempt a use of a substance to be included in Annex XIV the following elements should be considered:

•	There is existing Community legislation addressing the use (or categories of use) that is proposed to be exempted. Special attention has to be paid to the definition of use in the legislation in question compared to the REACH definitions. Furthermore, the reasons for and effect of any exemptions from the requirements set out in the legislation have to be assessed;
•	This Community legislation properly controls the risks to human health and/or the environment from the use of the substance arising from the intrinsic properties of the substance that are specified in Annex XIV; generally, the use in question should also specifically refer to the substance to be included in Annex XIV either by naming the substance specifically or by referring to the group the substance belongs to e.g. by referring to the classification criteria or the Annex XIII criteria;
•	This Community legislation imposes minimum requirements for the control of risks of the use. Firstly ‘the minimum requirements’ entails that the Member States may adopt more stringent but not less stringent requirements when implementing the specific Community legislation in question. Secondly, the piece of legislation has to define the measures to be implemented by the actors and to be enforced by authorities in a way that ensures the similar minimum level of control of risks throughout the EU and that this level can be regarded as proper. Legislation setting only the aim of measures or leaving the actual type and effectiveness of measures required ambiguous is not enough. Furthermore, attention should be paid on whether and how the risks related to the life-cycle stages resulting from the uses in question (i.e. service-life of articles and waste stage(s) as relevant) are covered.

From ECHA’s assessment of the available information, there appears to be no Community legislation regulating the use of DBP as an absorption oil in the purification of maleic anhydride (MAN).

Therefore, on the basis of the available information, ECHA does not see grounds for proposing a general exemption for that use of DBP in accordance with Art. 58(2) of REACH.

Furthermore, we would like to stress that the information on both the low level of risks and the availability and suitability of alternatives cannot be taken into account in defining whether this use warrants an exemption as there is no connection to existing specific Community legislation.
This information, however, may be part of the applications for authorisation to be submitted to ECHA (Art. 62(4) (d) – Chemical Safety Report and (e) – analysis of alternatives), and will be taken into account when the Agency needs to develop its opinions on any application and the European Commission takes a decision on whether to grant an authorisation and what type of conditions and how long review period such an authorisation will include.	
20090414	MSCA, Sweden	For the phthalates proposed to be included in Annex XIV a cumulative and aggregate (across different substances and different sources, respectively) risk assessment approach is warranted regarding their fertility and developmental effects due to similar or identical mode of action – in this case an anti-androgenic effect. So far, the ECHA Guidance on information requirements and chemical safety assessment only contains a very short section on this topic in Part E, p. 27. This area needs to be further developed and the guidance should be expanded. We also see a need for discussion in the ECHA Member State Committee and with the Competent Authorities how such approaches could be implemented in an appropriate way under the Authorisation procedure. 	We take note of the concerns raised regarding the potential additive or cumulative effects that may occur as a result of exposure of humans or the environment to different substances at the same time. The actual assessment of the magnitude of the potential risks that may occur through combined exposure is highly complex and needs substantial knowledge in terms of the exposure profile (which substances to take into account, at what level does the exposure occur and what is the spatial variability). In addition, in cases where the exposure profile would be known knowledge on the potential interactions that the different substances have in humans or environmental species needs to be known in order to be able to fully assess the potential effects of the combined exposure. 

Authorisations will be granted to specified actors (this can be manufacturers, importers or downstream users) who need to describe in their application the specific use or uses of the substance for which they request an authorisation. The Commission shall grant an authorisation if the risk to human health or the environment arising from the use of the substance is adequately controlled or, for substances falling under Article 60(3), may grant an authorisation if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. 

Taking into account this direct link between the actor, the use and the substance, it is difficult to envisage how in the decision-making process on an authorisation application for a specific substance the potential combined effects caused by exposure to other substances (which may or may not fall under the authorisation regime) can be taken into account. 

A potential exemption to the situation described above might be where the applicant makes use of the provisions provided for in Article 62(3) and submits an application dossier for a group of substances (fulfilling the requirements of section 1.5 of Annex XI). In cases where the applicant has based his grouping argumentation on a similar mode of (toxicological or ecotoxicological) action of the members of the group it could be expected that in the chemical safety assessment for this group the effects of potential combined exposure will also be addressed and therefore can be taken into account in the decision-making process.	
20090414	MSCA, The Netherlands	The Netherlands CA has submitted their comments on the justification already as part of the webforms for prioritisation. The Netherlands CA agrees with the recommendation for inclusion in Annex XIV of Dibutyl phthalate (DBP)	We thank you for your support.	

Transitional arrangements: comments on the proposal and conclusion
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090402	Council of Europe, EDQM, France, regional or local authority (on behalf of)	An article 58(2) exemption to annex XIV of Regulation (EC) No 1907/2006 corr is requested for the use of Dibutyl phthalate (DBP) for analytical purposes as prescribed in the European Pharmacopoeia, including use as a reference standard or as a reagent. Exemption for use in the International Pharmacopoeia of the World Health Organisation, when applicable, is also requested. Although analytical uses of the substance are carried out under controlled conditions with small quantities, the European Pharmacopoeia is continuously seeking for alternatives to substances of very high concern. The exemption is requested to prevent disruption in the supply of medicinal products in the EU market or in exportation of medicinal products from the EU to third countries.	See response given under “Substance specific comments related to prioritisation” section	
20090406	MSCA, United Kingdom	Earlier UK REACH CA comments: These substances have recently passed through the Existing Substances Regulation, including the agreement of risk assessments and, where deemed necessary, a risk reduction strategy. There is a need to reflect on how this recently-established EU regulatory position sits alongside a proposal that these substances should now be subject to Authorisation. Dibutyl phthalate (DBP): Di-isobutyl phthalate (DIBP) is presumably the most likely substitute, but we cannot tell if it is any more or less toxic to mammals than DBP itself. Table 0-3 presents some tentative DNELs, and GTA appears more toxic than some of the phthalates (e.g. via the oral route). Is that likely, given that it is derived from glycerol and acetic acid?	We thank you for your comment.

As far as your general comment is concerned, and as already mentioned in an above section of this document, the three phthalates were proposed for inclusion in Annex XIV on the basis of the prioritisation approach applied by ECHA for this first recommendation. They clearly fulfil the criteria for high volume and wide dispersive use. On the basis of the information generated and assessed under the ESR which has to be taken into account by the applicant (Annex I section 0.5), it could be assumed that applicants are able to demonstrate adequate control of risk in accordance with section 6.4 of Annex I. Therefore, provided that the other application requirements will be fulfilled it is not unlikely that an authorisation to use these substances can be obtained. However, authorisation applications need to include an analysis of alternatives. Where this analysis concludes that there are suitable alternatives available for the applicant, the application has to include also a substitution plan. Both the analysis of alternatives and, where available, the substitution plan can be used when defining a time-limited review period, any conditions or monitoring arrangements in the authorisation decision. The application requirements and the review obligation and any other decision conditions aim to promote substitution

As for your specific comment on DBP, we would like to clarify that the information collected by ECHA and its consultants about alternatives to the proposed substances does not aim to identify potential alternatives or to assess the technical or economic feasibility of such alternatives or risks related to them. This information is collected (and presented) to obtain an overview of the level of information available on the alternatives and the nature of the alternatives. In other words, this part of the assessment is not judging whether the alternatives are feasible or safer or how long it could take to transfer to the alternatives, but whether or not information seems to be available that facilitates compiling an analysis of alternatives by the future potential applicants. Therefore, as also indicated in the general approach papers dedicated respectively to the prioritisation and draft recommendation (attached as annexes to this recommendation), the availability and suitability of alternatives are criteria which have been taken into account by ECHA neither to make its priority setting nor to develop its draft recommendation for DBP. This information may however be part of the applications for authorisation to be submitted to ECHA (Art. 62(4) (e) – analysis of alternatives and (f) -) substitution plan), and will be discussed and taken into account only at that further step in the authorisation procedure.	
20090407	WWF (on behalf of CHEM Trust, Greenpeace, HEAL and WWF), Belgium, International NGO (on behalf of)	Page 2 The timelines foreseen for transitional arrangements are too long and should be shortened to 18 months (sunset date 36 months) after the date of inclusion in Annex XIV as foreseen in the Guidance on inclusion of substances in Annex XIV (p.35). Given that alternatives for many uses seem to be available and a lot of research has already been done, these long transitional arrangements seem excessive. Moreover, the substance was already banned for consumer preparations, which signalled to companies the urgent need to look for replacements. These long timelines will disadvantage those companies selling safer alternatives, materials or technologies. Many electronic companies, among others, have already eliminated the use of all phthalates or are committed to do so in the next few years. For more information please consult the latest Greenpeace’s “Guide to Greener Electronics” at http://www.greenpeace.org/international/campaigns/toxics/electronics/how-the-companies-line-up 	We thank you for your comment.

However, we would like to stress that the reasons for proposing as the earliest application date 24 months from the inclusion of the substance into Annex XIV are explained in section 3.2 of the document ‘General Approach for Defining the Annex XIV entries’, which is being published as a supplementary document to ECHA’s Recommendation. As for the grounds for further extending this minimum period for DBP, these are provided in Annex I of ECHA’s Recommendation (substance specific document I. G.). In particular, please note that the level of information available on the alternatives and the nature of the alternatives are elements which have already been taken into account by ECHA for its recommendation.
Therefore, on the basis of the information available, ECHA does not see grounds for proposing shortening the application and sunset dates for DBP.
	
20090408	Finnish Defence Forces (FDF), Finland, national authority (on behalf of)	DBP has been used worldwide in the production of propellants for decades. As propellants constitute one of the key elements in preparedness for military activities, considerable amounts of military propellants have been stored, together with DBP as one of the raw materials for these propellants. Such propellants are kept in store for considerable lengths of time, normally for decades. This implies that currently both DBP and propellants containing DBP, to be understood as mixtures in REACH terminology, are in store. Their use for the production of military propellants and propelling charges is, according to our understanding, to be considered as releasing to the market. 	See response given under “General comments on the justification” section	
20090413	Federal Ministry of Trade and Industry, Egypt, national authority (on behalf of)	Page 2: We agree, that DEHP was identified as a candidate substance according to Article 57(c).
	We thank you for your support.	
20090414	Emerson Process Management – Rosemount Nuclear Instruments, United States, company (on behalf of)	The use of DBP in pressure transmitters for nuclear power installations [the company] is concerned with, the qualification process of possible substitutes is subject to the very high safety requirements of the nuclear industry. The selection of materials of construction and their performance requires extensive qualification testing to international nuclear power standards such as IEEE 323 and 344, and KTA 1401 and 3505. Material changes to the product, subsequently, require re-qualification. Re-qualification must be evaluated and approved by the end customer. The process is necessary to ensure compliance with the customer’s operational licenses and/or permits. In order to change this barrier compound, an acceptable substitute must first be found. Once identified, the time to complete this comprehensive testing regime is in the order of years and that assumes the product passes the first time through; if not the entire process starts all over (see more details in the comments on the review periods). Therefore, the timelines involved are not compatible with the proposed transitional arrangements. The time for the preparation of the application, in particular for the analysis of alternatives, as well as the time between requesting an “Authorised Use” and the “Sunset Date” would be insufficient to meet the nuclear power industry requirements for material substitution. 	As already mentioned in our response to another section of your comment, the information on the availability and suitability of alternatives cannot be taken into account in defining whether this use warrants an exemption as there is no connection to existing specific Community legislation.
This information, however, may be part of the applications for authorisation to be submitted to ECHA (Art. 62.4 (d) – Chemical Safety Report and (e) – analysis of alternatives), and will be taken into account when the Agency needs to develop its opinions on any application and the European Commission takes a decision on whether to grant an authorisation and what type of conditions and how long review period such an authorisation will include.    	
20090414	Huntsman (Europe) BVBA, Belgium, company (on behalf of)	See above	See response given under “General comments on the justification” section	
20090414	MSCA, Sweden	We agree to the proposal of 30/48 months application/sunset dates. The justification seems appropriate.
	We thank you for your support.	
20090414	MSCA, The Netherlands	The Netherlands CA agrees with the transitional arrangements as proposed by ECHA. 
	We thank you for your support.	

Transitional arrangements: comments on the justification
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090402	Council of Europe, EDQM, France, regional or local authority (on behalf of)	See general comments and comments on the proposal and conclusion.
		
20090408	Finnish Defence Forces (FDF), Finland, national authority (on behalf of)	See general comments on the justification		
20090413	Federal Ministry of Trade and Industry, Egypt, national authority (on behalf of)	Page3: Since the supply chain involves many uses/users and replacements are not readily available, the sunset date should be extended to 60 months.
	We thank you for your comment.

However, we would like to clarify that the complexity of the supply chain is a criteria which has already been taken into account by ECHA when developing its recommendation for transitional arrangements.

Moreover, it has to be noted that an application for authorisation can be submitted even if replacements are not yet available.
The information on the alternatives and factors affecting the possibilities to transfer to them can be presented as a part of the applications for authorisation to be submitted to ECHA (Art. 62.4 (e) – analysis of alternatives and 62(4) (f) – substitution plan), and will be taken into account when the Agency needs to develop its opinions on any application and the European Commission takes a decision on whether to grant an authorisation and what type of conditions and how long review period such an authorisation will include.	
20090414	Emerson Process Management – Rosemount Nuclear Instruments, United States, company (on behalf of)	The use of DBP in pressure transmitters for nuclear power installations is only concerned by the second criteria “availability of alternatives”. Here the constraints on the transfer to alternatives resulting from the nuclear power application of DBP must be considered and should justify an exempted use from the authorisation requirement or longer transitional arrangements.	See responses given under “General comments on the justification” and “Transitional arrangements: comments on the proposal and conclusion” sections	
20090414	Huntsman (Europe) BVBA, Belgium, company (on behalf of)	See above		
20090414	MSCA, Sweden	See above		

Uses (or categories of uses) exempted : comments on the uses proposed to be exempted
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090402	Council of Europe, EDQM, France, regional or local authority (on behalf of)	See general comments and comments on the proposal and conclusion.
		
20090407	WWF (on behalf of CHEM Trust, Greenpeace, HEAL and WWF), Belgium, International NGO (on behalf of)	Page 4 The exemption should be deleted, as it is not appropriate to exempt the use of DBP in artists paints. It is not justified to automatically take over this general exemption from the previous legislation where the derogation for artists paints had been established for all CMRs. Moreover, it is questionable if the exemption is needed, given the fact that it is apparently not used in these paints anyway. 	We thank you for your comment.

We agree that an exemption from the authorisation requirement under Article 58(2) would not be satisfied solely on the basis that Annex XVII includes (some kind of) restriction on the substance. However, where an entry in Annex XVII exempts a specific use of a substance from the restrictions Article 58(2) could be used to exempt that specific use. We see two such situations: 

i)	Annex XVII includes a restriction on a specified use of a substance and this restriction specifies condition(s) under which the restriction does not apply;
ii)	Annex XVII includes a generic ban on a substance and a specified use is exempted from this generic ban. Such an exemption can be subject to further conditions.  

In the draft recommendation the proposed exemption from the authorisation requirement on SCCPs is based on case i) and the proposed exemptions on DEHP, DBP, BBP and MDA are based on case ii). 

We believe that in such cases an assessment must have been made by the Community legislator in deciding to what extent such specific uses should be restricted leading to the specific entries made for such uses in Annex XVII (formerly Directive 76/769). 

In ECHA’s view the authorisation process should not put into question such assessments made by the Community legislator in the restrictions process. Indeed, recital 80 of the REACH Regulation provides that ‘The proper interaction between the provisions on authorisation and restriction should be ensured in order to preserve the efficient functioning of the internal market and the protection of human health, safety and the environment. Restrictions that exist when the substance in question is added to the list of substances, for which applications for authorisation can be submitted, should be maintained for that substance. …’

The proposed approach guarantees a proper interaction between the two instruments.

However, if exemptions, derogations or conditions included in the entries of Annex XVII are of concern and further measures may be needed to address these concerns, a revision of these entries should have been initiated.	
20090408	Finnish Defence Forces (FDF), Finland, national authority (on behalf of)	Because of the natural constraints combined with defence and preparedness issues, an authorisation application including specific uses, amounts and sites is likely to require inclusion of classified information. This makes compiling and handling of such applications problematic at the least, with consideration to other applicable legislation. Military propellants and related substance and mixtures are strictly governed by special legislation and inter military surveillance mechanisms. This legislation contains general requirements for machinery, facilities, management, detailed work instructions, protective measures, and training of workers. Due to the inherent risks related to manufacturing, handling, using, storing, transporting and disposing of military substances, mixtures and equipment, there is a long tradition and routine of applying the aforementioned requirements. 	See response given under “General comments on the justification” section	
20090409	Explosia a.s, Czech Republic, company (on behalf of)	p.1 We propose to exempt utilization of dibutylphthalate in explosives from the obligation to authorize the substance according to 1907/2006 REACH regulation. Dibutylphthalate is used in smokeless powders to modify ballistic properties. It is worked in the product and no further release occurs in subsequent manipulation and processing. Smokeless powders are used as propelling charges for ammunition, where the powder is hermetically sealed. When used in a weapon the temperature rises after firing up to 3,000 K and all powder components burn to form carbon oxides and water. Therefore any release of dibutylphthalate into environment can be practically excluded if smokeless powders are used under normal conditions. At present the search is in progress for a substance to replace dibutylphthalate in smokeless powders. The development has not been completed yet. 	We thank you for your comment.

However, we would like to clarify that, according to Article 58(2) of the REACH Regulation, “Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled….”

Accordingly, in light of this provision and the guidance on inclusion of substances in Annex XIV, in order to exempt a use of a substance to be included in Annex XIV the following elements should be considered:

•	There is existing Community legislation addressing the use (or categories of use) that is proposed to be exempted. Special attention has to be paid to the definition of use in the legislation in question compared to the REACH definitions. Furthermore, the reasons for and effect of any exemptions from the requirements set out in the legislation have to be assessed;
•	This Community legislation properly controls the risks to human health and/or the environment from the use of the substance arising from the intrinsic properties of the substance that are specified in Annex XIV; generally, the use in question should also specifically refer to the substance to be included in Annex XIV either by naming the substance specifically or by referring to the group the substance belongs to e.g. by referring to the classification criteria or the Annex XIII criteria;
•	This Community legislation imposes minimum requirements for the control of risks of the use. Firstly, ‘the minimum requirements’ entails that the Member States may adopt more stringent but not less stringent requirements when implementing the specific Community legislation in question. Secondly, the piece of legislation has to define the measures to be implemented by the actors and to be enforced by authorities in a way that ensures the similar minimum level of control of risks throughout the EU and that this level can be regarded as proper. Legislation setting only the aim of measures or leaving the actual type and effectiveness of measures required ambiguous is not enough. Furthermore, attention should be paid on whether and how the risks related to the life-cycle stages resulting from the uses in question (i.e. service-life of articles and waste stage(s) as relevant) are covered.

There appears to be no Community legislation regulating the use of DBP in explosives. Therefore, on the basis of the available information, there seem not to be grounds for proposing an exemption for that use in accordance with Art. 58(2) of REACH.

Furthermore, we would like to stress that the information on both the low level of risks and the availability and suitability of alternatives cannot be taken into account in defining whether this use warrants an exemption as there is no connection to existing specific Community legislation.
This information, however, may be part of the applications for authorisation to be submitted to ECHA (Art. 62(4) (d) – Chemical Safety Report and (e) – analysis of alternatives), and will be taken into account when the Agency needs to develop its opinions on any application and the European Commission takes a decision on whether to grant an authorisation and what type of conditions and how long review period such an authorisation will include.	
20090410	European Federation of Pharmaceutical Industries and Associations, industry or trade association (on behalf of)	Use in the immediate packaging of medicinal products and the immediate packaging of active substances for medicinal products. No medicinal product may be placed on the market of a Member State unless a marketing authorization has been issued by the competent authorities of that Member State in accordance with Directive 2001/83/EC or unless an authorisation has been granted in accordance with Regulation (EC) No 726/2004. Marketing authorizations are granted based on the assessment of extensive dossiers. These dossiers include inter alia detailed information on the packaging and packaging materials.Stringent requrements are applied. In the case of “plastic immediate packaging materials, i.e. packaging materials intended to be in direct contact with the active substance or medicinal product”, the requirements are outlined in guideline reference CPMP/QWP/4359/03/EMEA/CVMP/04 dated 19th May 2005 which is accessible using the following link http://www.emea.europa.eu/pdfs/human/qwp/435903en.pdf. The scope of the guideline is given in the guideline. In particular it is stated that “plastic immediate packaging materials for active ingredients and medicinal products have to comply with the requirements in this document, regardless whether the material is going to be used for the first time or has already been used for packaging of active substances or medicinal products.” The requirements cover quality, stability and safety aspects. More details are provided in the attached document Therefore it is justified that the substances contained in the immediate packaging materials of active substances or medicinal products “within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use” are exempted from the authorisation requirement. If for some reason it is considered that Article 2(5) of the REACH Regulation does not directly apply to substances contained in the immediate packaging materials for active substances or medicinal products, the legislation referred to in Article 2(5) makes substances contained in the immediate packaging materials for active substances or medicinal products meet the conditions for an exemption under Article 58 (2) of the REACH Regulation. For a number of reasons the identification and implementation of possible alternatives would raise huge issues. (details are provided in the attached document) It is not the intention of the REACH Regulation to impact market availability of medicinal products that are adequately regulated through other European directives and regulations. This is underlined by Recital 111 stating: “It is important to avoid confusion between the mission of the Agency and the respective missions of the European Medicines Agency (EMEA) established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency”… as well as by Articles 2(5A) and 58 (2). 	On the basis of the available information, ECHA is currently not in a position to assess fully the possible consequences of the existing Community legislation on medicinal products and its implementation measures taken by the European Medicines Agency on the provisions of Title VII of the REACH Regulation applied to substances used in primary/immediate packaging of medicinal products. Therefore, this comment needs further investigation before ECHA will provide a response in the final “Response to comments” document.
	
20090413	Federal Ministry of Trade and Industry, Egypt, national authority (on behalf of)	No comment
		
20090414	Emerson Process Management – Rosemount Nuclear Instruments, United States, company (on behalf of)	Though not specifically spelled out as an authorised use, such as use of DBP in artists’ paints under Directive 1999/45/EC, the use of DBP in pressure transmitters in the nuclear power industry is already permitted under the current Community legislation, i.e. Directive 76/769/EC and Annex XVII of REACH. In this specific use of DBP indeed, the substance is not supplied to the general public, but handled by technical experts from the industry. Moreover, the risks related to this specific use of DBP are properly controlled until the end of life of the products, making any exposure to the substance either to the human health or the environment highly unlikely. The pressure transmitters are not available to users outside of the nuclear power industry. The DBP is sealed within the product that can withstand external pressures of 70 psi to 110 psi. Exposure to the substance is only possible if the unit is opened and the coating disturbed. This is highly unlikely under normal or expected use and therefore does not represent a risk to the user during product use. Moreover, the amount of dibutyl phthalate is small in comparison to the overall weight of the instrument purchased by the customer. Depending on the model configuration, the amount is typically 0.02% or less of the final weight of the instrument (epoxy coating is a two part system in which dibutyl phthalate is a component in Part B in a concentration of 10-30%; when used in the transmitter, approximately 1-2 gram of mixed coating is used). Furthermore, once the instrument reaches the end of its useful life, it represents little to no risk to the environment, since the materials used to make the instruments have a high value in the materials recycling markets. The metal housings, to which the coating is adhered, are melted and recast for other or similar uses. This coating is not normally separated from the metal and as a result is destroyed in the melting process. Along with the safety requirements of the nuclear power industry making changes to legacy qualifications very undesirable, the critical role of pressure transmitters for the safety of nuclear powerr installations must be stressed. Pressure transmitters play a critical role in controlling the reactor coolant and mitigating the accident risk in nuclear power plants. Pressure transmitters make up the reactor coolant pressure boundary enabling safe start-up and shut down of the reactor. They are used to measure pressure, flows and levels in pipes, tanks and the reactor thereby insuring safe operation. They can be found on all types of nuclear power reactor technologies, e.g. Pressurized Water Reactors and Boiling Water Reactors. Therefore, [the company] believes an exemption of this use of DBP is justified rather than requesting an authorised use at a later date. 	See responses given under “General comments on the justification” and “Transitional arrangements: comments on the proposal and conclusion” sections	
20090414	Allgemeine Unfallversicherungsanstalt, Austria, national authority (on behalf of)	Regarding the exemptions of uses we demand: Artists’ paints only should be exempted from the authorisation requirement in the case 1) of being evident that the substance is used in artists’ paints 2) there is no alternative substance available. 	We thank you for your comment.

We agree that an exemption from the authorisation requirement under Article 58(2) would not be satisfied solely on the basis that Annex XVII includes (some kind of) restriction on the substance. However, where an entry in Annex XVII exempts a specific use of a substance from the restrictions Article 58(2) could be used to exempt that specific use. We see two such situations: 

i)	Annex XVII includes a restriction on a specified use of a substance and this restriction specifies condition(s) under which the restriction does not apply;
ii)	Annex XVII includes a generic ban on a substance and a specified use is exempted from this generic ban. Such an exemption can be subject to further conditions.  

In the draft recommendation the proposed exemption from the authorisation requirement on SCCPs is based on case i) and the proposed exemptions on DEHP, DBP, BBP and MDA are based on case ii). 

We believe that in such cases an assessment must have been made by the Community legislator in deciding to what extent such specific uses should be restricted leading to the specific entries made for such uses in Annex XVII (formerly Directive 76/769). 

In ECHA’s view the authorisation process should not put into question such assessments made by the Community legislator in the restrictions process. Indeed, recital 80 of the REACH Regulation provides that ‘The proper interaction between the provisions on authorisation and restriction should be ensured in order to preserve the efficient functioning of the internal market and the protection of human health, safety and the environment. Restrictions that exist when the substance in question is added to the list of substances, for which applications for authorisation can be submitted, should be maintained for that substance. …’

The proposed approach guarantees a proper interaction between the two instruments.

However, if exemptions, derogations or conditions included in the entries of Annex XVII are of concern and further measures may be needed to address these concerns, a revision of these entries should have been initiated.	
20090414	Huntsman (Europe) BVBA, Belgium, company (on behalf of)	For correct formatting the comments submitted also as pdf. As described below, we propose that the use of dibutyl phthalate (DBP) as an absorption oil in the purification of maleic anhydride (MAN) is exempted from the authorisation requirement under Article 58(2) of the REACH Regulation because there is existing specific Community legislation imposing minimum requirements that properly control any risks to human health or the environment, namely Directives 76/769/EC, 98/24/EC and 96/61/EC. The patented manufacturing process for which we are claiming exemption is simply described according to the attached block flow diagram and is more fully characterized according to registered patent EP00928782 and other patents. For the avoidance of doubt, the exemption is only proposed for processes that use DBP as an absorption oil in the purification of MAN at an equivalent or higher level of control of human health and environmental risks as the process described here. Product purity under Directive 76/769/EEC. DBP is a substance whose use is restricted by Directive 76/769/EEC on the marketing and use of certain dangerous substances and preparations. This restriction can be found in entries 31 and 51 of that Directive as well as in entries 31 and 51 of Annex XVII of the REACH Regulation. Annex I of Directive 76/769/EEC permits use of DBP under certain conditions mentioned in the Draft Recommendation. To summarise the restrictions, pursuant to entry 31 use of DBP in concentrations lower than 0.5% is permitted apart from uses, pursuant to entry 51, in a preparation, at concentrations greater than 0.1% by mass of the plasticised material, in toys and childcare articles. There are also particular categories of exempted uses such as use in artists' paints.  The concentration of DBP in purified maleic anhydride placed on the market is consistently below 10 ppm, i.e. more than 100 times below the lowest threshold described in Directive 76/769/EEC.  By way of example only, in the most recent (4 to 6 March 2009) finished product MAN samples, no DBP could be detected, with a detection limit: 10 mg DBP / kg MAN. Historical records demonstrating the purity of the product can be provided on request. Occupational health protection under Directive 98/24/EC. Occupational health risks of DBP are controlled by the requirements of Directive 98/24/EC for the protection of the health and safety of workers from the risks related to chemical agents at work. 98/24/EC names DBP by reference to 67/548/EC in Article 2(b)(i) and imposes minimum requirements relating to the protection of workers' health in Articles 3-11.  In the manufacture of MAN using DBP as an absorption oil, each employee is a skilled worker who has passed a 3.5 years-apprenticeship according to the German regulations enacted pursuant to the cited Directives.  Before a new employee is allowed to work in the plant autonomously, he receives a thorough training on the plant specifics by the plant manager, the foremen and his colleagues. The relevant chapters of the Manual Operating Guideline (MOG) are taught at regular intervals.  A special training on CMR substances (including DBP) has to be passed every year (documentation on E-Learning system can be provided on request).  A preventive medical check-up of each employee is carried out at least every three years according to the rules of the German professional insurance (Berufsgenossenschaft, BG). Pollution prevention and control under Directive 96/61/EC. The DBP emissions are controlled by Directive 96/61/EC on integrated pollution prevention and control (IPPC). This imposes an IPPC facility permit for all facilities under German legislation implementing the Directive. The Directive sets up a system of permits for new installations for the control and prevention of pollution in Articles 3-23. DBP is included by means of a reference in Article 2(i).  At the present time and during the foreseeable future based on current knowledge, the consumption of DBP in the process described here is and will be in the 100-1000 metric tonnes band, subject to REACH registration in 2013. This DBP consumption range takes into account the publicly announced expansion of the Sasol-Huntsman GmBH & Co. KG. Moers plant to come on stream 2011.  All on-site and off-site waste streams that may contain DBP are incinerated under CEMs, under on-line control with the authorities.  The on-site incineration. On-site incineration is carried out according to German Technical Instructions on Air Quality Control (TA Luft) and the operation permits / authority approvals. Typical temperatures inside the combustor are > 800 to 850°C . The emission limit for organic carbon is 50 mg/m³ incinerator off-gas.  Carbon monoxide (CO, emission limit 80 mg/m³) has to be monitored continuously (according to TA Luft, 13th German Verordnung zur Durchführung des Bundes-Immissionsschutz-gesetzes (BImSchV), and permit) and data have to be transmitted to the authority (district government, environmental surveillance department; Bezirksregierung Abteilung Umweltüberwachung) on-line (so called EFÜ (emission remote surveillance) system).  By these measures DBP emissions via on-site incineration should be absolutely minimal.  The off-site waste incineration plant. High-boiling distillation residues have to be incinerated off-site.  The off-site incinerator also has its own authority approval and is under the strict and permanent supervision of the authority (district government, environmental surveillance department; Bezirksregierung Abteilung Umweltüberwachung).  Facility waste is given to an approved waste incineration plant in accordance with the facility’s waste disposal permit.  The transport from the facility to the external waste disposal unit is carried out by a licensed operator (usually a certified disposal company) with trained drivers. The waste is almost solid and so it is easy to contain in case of an environmental incident during transport.  In order to destroy all organic compounds according to 17th BImSchV, the off-site combustor temperature has to be at least 850°C for a gas residence time of at least 2 s.  In waste incineration plants many emission parameters have to be monitored continuously and transmitted to the authority on-line (via the above mentioned EFÜ system).  Any solid waste sent for disposal off-site is also incinerated at a permitted hazardous waste incinerator subject to standards at least as stringent as those at the facility, and monitored by the governmental authorities with on-line CEMs. Therefore, DBP emissions due to off-site disposal are minimal as well.  The substance class, DBP belongs to, has a threshold value for reporting of 250 grams per year at each plant.  In the latest declaration, the reporting cycle being every 4 years, for the years 2000-2004, no emissions for DBP had to be reported in accordance with the authority (district government, environmental surveillance department; Bezirksregierung Abteilung Umweltüberwachung). This means that there were less than 250 grams of DBP emissions into the air per year.  We submit that the authorisation requirement for the use of DBP as an absorption oil in the production of MAN would be disproportionate related to the nature of the substance under Article 58(2) of the REACH Regulation, as the substance is handled under strictly controlled conditions during its life cycle at the MAN plant as described below. 1. The substance is rigorously contained by technical means during its whole life cycle including manufacture, purification, cleaning and maintenance of equipment, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage.  In the MAN production process the substance is handled in a closed system that complies with the European and adopting German legislation with regard to environmental, process safety and occupational health & safety protection.  TA Luft prescribes the quality and the tightness of sealings/gaskets in the plant.  11th BImSchV (ordinance on emission declaration): For the substance class, DBP belongs to the threshold value for reporting is 250 grams per year and plant  In the latest declarations for the years 2000 and 2004, no emissions for DBP had to be reported in accordance with the authority (district government, environmental surveillance department; Bezirksregierung Abteilung Umweltüberwachtung).  This means that were less than 250 grams of DBP emissions into the air per year.  Every operation which requires the opening of closed systems (e.g. taking samples for analysis, cleaning of filters, washing procedures, unloading of fresh DBP, emptying of pumps or vessels for maintenance) is described in the Manual Operating Guideline (MOG). For each of these operations there are operating instructions according to § 14 of the German Gefahrstoffverordnung (GefStoffV).  Each employee has to pass a training course for these operating instructions every year.  These trainings are being documented in a computer-based E-Learning system. Supervision of the completeness of these trainings is done by the plant manager and the SHERQ (Safety, Health, Environment, Risk and Quality Management)  All operating instructions focus on the minimisation of emissions and employee exposure by Personal Protective Equipment (PPE) during these operations.  As previously discussed, all of these requirements are imposed by German legislation and permits implementing European Community Directives. 2. Procedural and control technologies shall be used that minimise emission and any resulting exposure. • For minimisation of emissions and exposure, see 1. All operations described above and adherence to the rules are supervised by at least the foremen and the plant manager. 3. Only properly trained and authorised personnel handle the substance.  Each employee is a skilled worker who has passed a 3.5 years-apprenticeship according to the German regulations.  Before a new employee is allowed to work in the plant autonomously, he receives a thorough training on the plant specifics by the plant manager, the foremen and his colleagues.  The relevant chapters of the MOG are taught at regular intervals.  A special training on CMR substances (including DBP) has to be passed every year (documentation in E-Learning system).  A preventive medical check-up of each employee is carried at least every three years according to the rules of the German professional insurance (Berufsgenossenschaft, BG). 4. In the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered  For special plant shut-downs and cleaning procedures, specific plans and procedures have been developed. Copies of such plans can be provided on request.  Risk assessments involving the engaged service providers and own employees are conducted.  Warnings for probable specials risks are given on the compulsory work permits by the plant manager. 5. In cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures.  In case of a DBP leakage, the substances are caught on the sealed floor of the plant, brought together in a system of channels and pipes, and finally collected in a closed slop vessel.  As discussed, for off-site waste disposal, external certified specialist companies are contracted. 6. Substance-handling procedures are well documented and strictly supervised by the site operator.  Every operation which requires the opening of closed systems (e.g. taking samples for analysis, cleaning of filters, washing procedures, unloading of fresh DBP, emptying of pumps or vessels for maintenance) is described in the Manual Operating Guideline (MOG).  For each of these operations there are operating instructions according to § 14 of the German Gefahrstoffverordnung (GefStoffV).  Each employee has to pass a training of these operating instructions every year. These trainings are being documented in a computer-based E-Learning system.  Supervision of the completeness of these trainings is done by the plant manager and the SHERQ department.  All operating instructions focus on the minimisation of emissions and employee exposure by Personal Protective Equipment (PPE) during these operations. All documents referred to herein are available to ECHA on its request. We respectfully submit that the use of dibutyl phthalate (DBP) as an absorption oil in the purification of maleic anhydride (MAN) is exempted from the authorisation requirement. ATTACHMENTS: 1. Huntsman MAN Process Flow 

+ See attachment	See response given under “General comments on the justification” section	
20090414	MSCA, Sweden	We have difficulties agreeing with the argumentation for the exemption for DBP in artists´ paint based solely on the fact that such use is permitted under the limitations directive. Directive 76/769/EEC stipulates prohibitions with exemptions while authorisation under REACH may or may not result in the granting of authorisation depending on e.g. the level of control of risks. Thus, any analysis of advantages and drawbacks, risks, alternatives etc. that was relevant in deciding not to ban DBP in artists´ paint under the limitations directive is not necessarily relevant in deciding whether the use of the substances should be exempted from authorisation. Furthermore, we have seen no data indicating that DBP is presently used or could technically be used in artists´ paint, potentially making the proposed exemption unnecessary. 	We thank you for your comment.

We agree that an exemption from the authorisation requirement under Article 58(2) would not be satisfied solely on the basis that Annex XVII includes (some kind of) restriction on the substance. However, where an entry in Annex XVII exempts a specific use of a substance from the restrictions Article 58(2) could be used to exempt that specific use. We see two such situations: 

i)	Annex XVII includes a restriction on a specified use of a substance and this restriction specifies condition(s) under which the restriction does not apply;
ii)	Annex XVII includes a generic ban on a substance and a specified use is exempted from this generic ban. Such an exemption can be subject to further conditions.  

In the draft recommendation the proposed exemption from the authorisation requirement on SCCPs is based on case i) and the proposed exemptions on DEHP, DBP, BBP and MDA are based on case ii). 

We believe that in such cases an assessment must have been made by the Community legislator in deciding to what extent such specific uses should be restricted leading to the specific entries made for such uses in Annex XVII (formerly Directive 76/769). 

In ECHA’s view the authorisation process should not put into question such assessments made by the Community legislator in the restrictions process. Indeed, recital 80 of the REACH Regulation provides that ‘The proper interaction between the provisions on authorisation and restriction should be ensured in order to preserve the efficient functioning of the internal market and the protection of human health, safety and the environment. Restrictions that exist when the substance in question is added to the list of substances, for which applications for authorisation can be submitted, should be maintained for that substance. …’

The proposed approach guarantees a proper interaction between the two instruments.

However, if exemptions, derogations or conditions included in the entries of Annex XVII are of concern and further measures may be needed to address these concerns, a revision of these entries should have been initiated.	
20090414	MSCA, The Netherlands	The Netherlands CA agrees with the uses exempted from the authorisation requirement as proposed by ECHA.	We thank you for your support.	

Other uses (categories of uses) to be exempted and existing Community legislation imposing on this (category of) use of the substance minimum requirements relating to the protection of human health or the environment
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090326	Germany, company (on behalf of)	Document reference: http://echa.europa.eu/doc/consultations/recommendations/justifications/justif_dbp.pdf, page 4, section "5.Proposed exempted categories of use". Proposal: To exempt from the authorisation requirement the placing on the market of DBP in a preparation for the supply to industrial users for the use as analytical standard for test and measurement instruments. Justification: Defined substance samples are required to calibrate analytical instruments to identify and quantify the substance (e.g. for measurement solutions used by enforcement agencies). The applications are laboratory use by professional users (minimal risk to consumers and the environment, controlled professional use and disposal). The volumes required for calibration samples (analytical standards) are minimal, typically a solution in the range of millilitres. The concentration of the chemical standard substance is normally low - in the range of 0.1%-2% and often lower according to the sensitivity of the measuring technique. For existing or future development of new highly sensitive analytical test solutions (e.g. using mass spectroscopy, chromatography, optical spectroscopy, etc.), the use of analytical standards for calibration purposes is indispensable and is required for deployment of technical verification instruments for operational enforcement of environmental policies. A substitution of the substance of concern is technically not possible due to the calibration purpose of the usage. Our company does currently not have industry data with respect to volumes or concentrations of DBP used in analytical standards, but is committed to provide a constant stream of new measurement solutions to the environmental measurement market place. Comment on Terminology: Analytical standards are sometimes also named chemical standards, calibration standards, reference standards or samples or test samples.  	See response given under “General comments on the prioritisation” section	
20090326	Germany, company (on behalf of)	Proposed in Directive Annex III on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) Reference http://ec.europa.eu/environment/waste/weee/pdf/com_2008_809.pdf		
20090410	European Federation of Pharmaceutical Industries and Associations, Belgium, industry or trade association (on behalf of)	See attachment	See response given under “Uses (or categories of uses) exempted : comments on the uses proposed to be exempted” section	
20090410	Belgium, company (on behalf of) – Company “X”	DBP used as component of Ziegler-Natta catalysts for the production of polypropylene (PP) This phthalate is indeed used as component of Ziegler-Natta catalysts, the catalysts most widely used for the production of polypropylene. As a consequence it will also affect the polypropylene users, the plastics converters. The role of the catalyst in the manufacture of polypropylene is essential as it primarily allows monomers to polymerise into macromolecules of a defined composition. Without catalyst, no polymerisation is possible. The role of the phthalate in the catalyst is to help to control specific physico-chemical properties of the polymer, and thus produce specific types of polypropylene tailor-made for the various applications existing in the market. So far, attempts to substitute this phthalate by other chemicals has not been successful in the sense that the desired physico-chemical characteristics could not be preserved or that the manufacture of the polymer was not possible in the same industrial process conditions. [The company] thinks that an exemption of authorization for the use of this phthalate in catalysts for polypropylene production should be granted based on the following arguments that demonstrate that the risks to human health and the environment are properly controlled: 1. Application of Article 58(2) Article 58(2) may give an exemption for uses when the risk is properly controlled. There exist several arguments to demonstrate this requirement. o Ziegler Natta catalysts are, due to the very nature of some of their components, preparations extremely sensitive to oxygen and humidity: contact with oxygen or traces of water would lead to their complete deactivation and make them totally unsuitable for polymerisation. They are thus produced in completely closed systems and conditioned and transported in closed containers maintained under inert atmosphere of nitrogen. o Their use during polymerisation is also strictly controlled and strictly confined in a closed reactor to avoid any degradation of the catalyst but also to avoid any release of monomers which could lead to severe risks of explosion due to their flammability characteristics. o Any traces of residual phthalate still present in the polypropylene at the end of the polymerisation stage, are entrapped in the polymer matrix and remain as impurities in the plastic, with very limited possibility to further migrate out of it and pose a risk to human health or the environment. 2. Application of Article 56(5): Food Contact legislation Article 56 paragraph 5(b) exempts from the authorisation process a substance included in Annex XIV and used in food contact applications within the scope of the Regulation (EC) 1935/2004 (Framework Regulation for materials in contact with foodstuffs). A specific daughter Directive of 1935/2004/EC, Directive 2007/19/EC on plastics in contact with food, authorizes the use of DBP as “technical support agent in polyolefins” up to 0.05%. This concentration level is much higher than the residual phthalate found in the final polypropylene products, which is around 1 ppm. (0.0001 %). Directive 2007/19/EC also introduces a Specific Migration Limit (SML) of 0.3 mg/kg food simulant for DBP. A complete risk assessment has been done to demonstrate the compliance of polypropylene produced with this SML: using recognised and well accepted simulation tools, this SML would be reached with a concentration level of 17 ppm of DBP in the polypropylene of the final article, there is thus an acceptable safety margin as the residual DBP found in PP is close to 1 ppm. 3. Niche application and market The consumption of DBP for this particular use is small compared to the other classical uses (as plasticiser mainly): it is estimated to be in the range 100 - 200 tonnes / year for the European production of polypropylene catalysts. 4. Importance of Polypropylene The benefits of polypropylene to society are widely recognized. Polypropylene is indeed used in a vast number of areas such as food packaging, consumer products, medical applications, electrical/electronic devices, automotive, building and construction, pipes and textiles. It is inert and does not contain plasticisers as its intrinsic characteristics are tailored by the use of specific catalysts, including the phthalate ones. Polypropylene amount to 19% of the total European plastics production in 2007 (10 out of 55 million tonnes).

+ See attachment	We thank you for your comment.

However, we would like to clarify the following:

Article 58(2) of the REACH Regulation provides that “Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled….”

Accordingly, in light of this provision and the guidance on inclusion of substances in Annex XIV, in order to exempt a use of a substance to be included in Annex XIV the following elements should be considered:

•	There is existing Community legislation addressing the use (or categories of use) that is proposed to be exempted. Special attention has to be paid to the definition of use in the legislation in question compared to the REACH definitions. Furthermore, the reasons for and effect of any exemptions from the requirements set out in the legislation have to be assessed;
•	This Community legislation properly controls the risks to human health and/or the environment from the use of the substance arising from the intrinsic properties of the substance that are specified in Annex XIV; generally, the use in question should also specifically refer to the substance to be included in Annex XIV either by naming the substance specifically or by referring to the group the substance belongs to e.g. by referring to the classification criteria or the Annex XIII criteria;
•	This Community legislation imposes minimum requirements for the control of risks of the use. Firstly ‘the minimum requirements’ entails that the Member States may adopt more stringent but not less stringent requirements when implementing the specific Community legislation in question. Secondly, the piece of legislation has to define the measures to be implemented by the actors and to be enforced by authorities in a way that ensures the similar minimum level of control of risks throughout the EU and that this level can be regarded as proper. Legislation setting only the aim of measures or leaving the actual type and effectiveness of measures required ambiguous is not enough. Furthermore, attention should be paid on whether and how the risks related to the life-cycle stages resulting from the uses in question (i.e. service-life of articles and waste stage(s) as relevant) are covered.

From ECHA’s assessment of the available information, it appears to be no Community legislation regulating the use of DBP as component of catalysts in the production of polypropylene.
Therefore, on the basis of the available information, ECHA does not see grounds for proposing a general exemption for that specific use in accordance with Art. 58(2) of REACH.

Moreover, when DBP is used in catalysts for the production of polypropylene but not as a constituent of a material in contact with food, there seem not to be a possibility to rely on the exemption  under  Art. 56(5) (b).

And finally, we would like to stress that the authorisation procedure does not foresee a possibility to exempt uses from the authorisation requirement on the basis of non-availability of alternatives and/or possible socio-economic impacts of inclusion of a substance in Annex XIV of REACH. However, the lack of suitable alternatives and the socio-economic benefits arising from the use of a substance are the conditions for granting an authorisation in accordance with Art. 60(4) (so called “socio-economic route” for authorisation).	
20090410	Belgium, company (on behalf of)	Directive 2007/19/EC
	See response above	
20090414	Emerson Process Management – Rosemount Nuclear Instruments, United States, company (on behalf of)	No comment
		
20090414	Bundesverband der Arzneimittel-Hersteller e.V., Germany, industry or trade association (on behalf of)	1) the use in primayr packaging of medicinal products 2) the use as reagent in the manufacture of medicinal products / APIs Please see attachment!!

+ See attachment	We thank you for your comment.

With respect to the use of the substances in primary packaging and use as a reagent for APIs and medicinal products, on the basis of the available information, ECHA is currently not in a position to assess fully the possible consequences of the existing Community legislation on medicinal products and its implementation measures taken by the European Medicines Agency on the provisions of Title VII of the REACH Regulation applied to substances used for such purposes. Therefore, this comment needs further investigation before ECHA will provide a response in the final “Response to comments” document.

With respect to the use of substances as reagents in the manufacture of API’s and for quality testing of medicinal products ECHA wishes to point out that such use may qualify as “scientific research and development”. Pursuant to Article 3(23) of REACH which defines “scientific research and development”, in combination with Article 56(3), the authorisation provisions do not apply to the placing on the market of a substance for any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year.

Therefore, ECHA is of the opinion that, provided that the use of the substance is actually in accordance with the definition of “scientific research and development” under REACH, and in particular fulfils its specific conditions, the placing on the market for this specific use would in any event not require an authorisation.	
20090414	Bundesverband der Arzneimittel-Hersteller e.V., Germany, industry or trade association (on behalf of)	Directive 2001/83/EC; Ph. Eur.
	See response above	

Information on the need to exempt PPORD from the authorisation requirement, including the maximum tonnage
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090413	Federal Ministry of Trade and Industry, Egypt, national authority (on behalf of)	Page 3: Since we have no replacement readily available for DEHP in its application in paints, the sunset date should be 60 months rather than 48 months. This would give us the chance to search for an alternative and also to incorporate the alternative substance in our products in order to achieve the same quality.	See response given under “Transitional arrangements: comments on the justification” section	
20090414	Emerson Process Management – Rosemount Nuclear Instruments, United States, company (on behalf of)	No comment

Review periods
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090413	Federal Ministry of Trade and Industry, Egypt, national authority (on behalf of)	No comment
		
20090414	Emerson Process Management – Rosemount Nuclear Instruments, United States, company (on behalf of)	Finding an appropriate review period is critical in the nuclear context. There are significant hurdles and extensive requalification testing when making material or design changes to nuclear qualified products. Typical testing includes aging (temperature and humidity), Vibration, Radiation, and “Loss of Coolant Accident (LOCA)” evaluations. The time necessary to make the changes is typically years. In order to change the barrier compound in [the company]’s pressure transducer which prevents moisture migration and contains dibutyl phthalate (less than 1 gram in each instrument), an acceptable substitute must first be found. Once identified, there are a significant number of tests the modified instrument must pass before it can be offered to the customer. For example, it may take a year or longer to get into position to conduct the testing. If an acceptable replacement material is identified, requalification effort begins. This process is extensive. For example, one of the global standards common in Europe (KTA 3505) consists of a 30g impact test, mechanical aging test, climatic cycling test background radiation test, and aging test which subjects the instrument to 1,000,000 pressure cycles, superimposed with temperature cycles over a period of 83 days. Once the instrument completes these test, it is then subject to accident testing to ensure it will perform without failure under various accident scenarios, such as seismic events, airplane crashes, steam releases, high radiation exposure, and flooding. Each step in the process carries the risk of failure and the need to repeat the step with a different material. Successful completion of these tests will result in a revision to [the company]’s specification documentation. [The company] must then let its customers know of the revision. The power stations will need to re-qualify the revised instrument. The time and effort needed for the re-qualification is dictated the level of severity the instrument is subjected to during its intended use. The revised documentation must also be submitted for regulatory review and approval, where required. This can add 3 to 12 months to the change process, depending on the priority of the end user. Additionally, there is no guarantee the modified instrument can be re-qualified. As a result, the need for spare parts becomes important. This process is also iterative in nature with information and documentation flowing between [the company] and prospective customer, thus adding to the resource commitments for both entities. If spare parts are not available, a new transmitter design must be qualified by the customer of use. This process is the same as qualifying a design modification and there is no guarantee the new design will be accepted. In summary, the process of change within the nuclear power industry is long, resource intensive and filled with numerous requirements, what would require several years of interval for the review. This, added to the very low quantity of dibutyl phthalate used and the low probability of the substance finding its way into the environment or being an exposure risk to those who handle the instrument, makes [the company] believe that an exemption of the use of DBP in pressure transmitters for nuclear installations is justified rather than requesting an authorised use at a later date. 	We thank you for your comment.

However, as already mentioned in our response to another section of your comment, the information on the availability and suitability of alternatives can be included in the applications for authorisation to be submitted to ECHA (Art. 62(4) (e) – analysis of alternatives), and will be taken into account when the Agency needs to develop its opinions on any application and the European Commission takes a decision on whether to grant an authorisation and what type of conditions and how long review period such an authorisation will include. 	

Attachments

BGFA:						

WWF:

European Council for Plasticisers and Intermediates:

European Federation of Pharmaceutical Industries and Associations:

Company “X”:

Bundesverband der Arzneimittel-Hersteller e.V.:

Huntsman (Europe) BVBA:

ISTAS: