01 June 2009

“Responses to comments” document for Benzyl butyl phthalate (BBP) (EC number: 201-622-7)

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	
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 or REACH.	
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, Poland	We support recommendation of Benzyl butyl phthalate (BBP) as a priority for inclusion in Annex XIV. We agree that BBP meets criteria ‘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 benzyl butyl phthalate in materials coming into direct contact with foodstuffs. 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 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.
Reviewing the existing Community legislation is indeed 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	
20090217	MSCA, Luxembourg	We support the prioritisation of BBP 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_bbp.pdf, page 4, section "5.Proposed exempted categories of use".
Proposal: To exempt from the authorisation requirement the placing on the market of BBP 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 BBP 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	BBP NL agrees with ECHA’s opinion to prioritize this substance, in our ranking the substance scored high priority (10) based on the following criteria: 1) Not a PBT/vPvB (score 0) 2) High volume use from end products: 8000 t/y (score 4) 3) Use as plasticizer in polymer articles which are used at many places results in high widespread use (score 3) 4) The release over time from articles is considered diffuse, uncontrolled and significant and resulting in exposure of workers, consumers and the environment (score 3)  	We thank you for your support and additional information.	
20090409	European Council for Plasticisers and Intermediates, Belgium, industry or trade association (on behalf of)	See attachment	We thank you for the further information you provided on DEHP and in particular on its manufacture, uses, releases and alternatives.
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 01 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	MSCA, Sweden	We support the prioritisation of BBP 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	We support the prioritisation of BBP for inclusion in Annex XIV. BBP is a HPV chemical and the use is wide dispersive. BBP is used in different types of industries and activities and the end products are used both by professional actors and consumers. The end products are widely distributed in the society. Prioritisation is therefore in accordance with the criteria for prioritisation article 58(3)(b) and (c). 	We thank you for your support.	
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 BBP.		
20090407	WWF (on behalf of CHEM Trust, Greenpeace, HEAL and WWF), Belgium, International NGO (on behalf of)	General comments on the justification CHEM Trust, Greenpeace, HEAL and WWF support the prioritisation for inclusion in Annex XIV due to the 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. 	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.	
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. BBP 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	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 benzyl butyl phthalate in materials coming into direct contact with foodstuffs. 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 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	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 Benzyl butyl phthalate (BBP)	We thank you for your support.	

Transitional arrangements: comments on the proposal and conclusion
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
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. Benzyl butyl phthalate: The information on substitutes is patchy, but presumably they could be prioritised for Evaluation at a later stage? Several aryl phosphate esters are highlighted as possible substitutes, and the UK Environment Agency will shortly be publishing authoritative reports for these. PEC/PNEC ratios are presented for some substitute substances (e.g. in Table 3-7), but we have not seen the original reports, so cannot comment on their appropriateness.	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 BBP, 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 BBP. 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 application date (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 are already 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 the urgent need for companies to look for safer replacements. These long timelines will create a competitive disadvantage to 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 BBP, these are provided in Annex I of ECHA’s Recommendation (substance specific document I. F). 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 BBP.	
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	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	
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	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	
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 BBP 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 dradt 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.	
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). 

+ See attachment	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	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	MSCA, Sweden	We have difficulties agreeing with the argumentation for the exemption for BBP 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 BBP 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 BBP 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_bbp.pdf
, page 4, section "5.Proposed exempted categories of use". Proposal: To exempt from the authorisation requirement the placing on the market of BBP 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 BBP 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, 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	
20090414	Bundesverband der Arzneimittel-Hersteller e.V., Germany, industry or trade association (on behalf of)	the use in primary packaging of medicinal products, pls see attachment!!

+ See attachment	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 immediate packaging of medicinal products. Therefore, this comment needs further investigation before ECHA will provide a response in the final “Response to comments” document.	
20090414	Bundesverband der Arzneimittel-Hersteller e.V., Germany, industry or trade association (on behalf of)	Directive 2001/82/EC
	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	

Review periods
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090413	Federal Ministry of Trade and Industry, Egypt, national authority (on behalf of)	No comments

Attachments

 WWF:	

European Council for Plasticisers and Intermediates:

European Federation of Pharmaceutical Industries and Associations:

Bundesverband der Arzneimittel-Hersteller e.V.:

ISTAS: