17 december 2010

Responses to comments Document (RCOM) for 2,4 – Dinitrotoluene (2,4-DNT) (EC number: 204-450-0)

This document provides ECHA’s responses to the comments received during the public consultation on the 2nd recommendation for inclusion of substances in Annex XIV of REACH which took place between 1 July and 30 September 2010.

I - General comments on the recommendation to include the substance in Annex XIV, including the prioritisation of the substance
#	Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
1	2010/09/29 	National authority
RIVM
Netherlands	The Netherlands CA agrees with the prioritization of 2,4 – Dinitrotoluene based on its CMR properties, the relevant volume for authorization and  uses that can be designated as wide-dispersive.	Thank you for your support	
2	2010/09/30 	National authority
Health and Safety Authority
Ireland	IE wish to acknowledge the work that ECHA has done in prioritising and recommending the 8 substances for inclusion in Annex XIV of the REACH Regulation
Following the 1st July commencement of the public consultation on ECHA’s recommendation of priority substances to be included in Annex XIV, the Irish Central Competent Authority forwarded a communication to possible Irish stakeholders, inviting them to comment as part of this public consultation. We have not been made aware of any relevant information which could be provided, in particular on uses which should be exempt from the authorisation process. 
On the basis of this, we have no objection to the recommendation to include the 8 substances in Annex XIV of REACH.	Thank you for this information and your support	
3	2010/09/30 	International NGO
International chemical secretariat
Sweden	This substance if deservingly being placed on Annex XIV considering its use as plasticizer in plastics, dyes, rubbers, munition, explosives and in photographic chemicals.	Thank you for the support and the additional information given. It would be useful if you could provide the reference(s) for this information and a more detailed description of the uses mentioned, if available.	
4	2010/09/30 	National authority
Portuguese Environment Agency - PT CA
Portugal	Taking into consideration the wide dispersion pattern of 2,4-Dinitrotoluene we consider that this substance fulfills the prioritisation criteria. However we consider that further analysis is required considering the proposed latest application date and sunset date.	Thank you for your comments.

Please see our resonse to comment 7.	
5	2010/09/30	International NGO
WWF European Policy Office
Belgium	We support the prioritisation for inclusion in Annex XIV due to its high volumes and dispersive use.	Thank you for your support.	

II - Transitional arrangements. Comments on the proposed dates
#	Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
6	2010/09/29 	Germany
	The German CA agrees with the proposed dates.	Thank you for your support	
7	2010/09/29 	National authority
RIVM
Netherlands	In the first round of Annex XIV prioritization, ECHA argued that the minimum time needed to prepare an application for authorization was 24 months (ECHA/MSC-8/2009/021). The Netherlands CA is of the opinion that in this and future rounds of setting dates for Annex XIV entries, this minimum time of 24 months needed should no longer be applied as the default value.
Furthermore, we suggest that the 24 month period could normally be considered as a maximum while a new minimum default time could be applied in this and future recommendations. 
It can be reasonably expected that, once ECHA gives it’s Annex XIV priority recommendation to the Commission, industry will anticipate this decision or even already will have anticipated the decision, since both the candidate list and the criteria for prioritization are publicly available.
In situations where no relevant information on the production cycle for a specific use is available (see REACH art. 58(1)(c)(i) ), a short standard time to the sunset date (and consequently the application date) can be recommended. In situations where the production cycle for a specific use is known and complex, a longer time for the application date could be considered. 
Default (minimum) times for Annex XIV entries with no specific information on the production cycle for specific uses, or evidence of simple supply chains could lead to e.g. 30 months for the sunset date and 12 months for the application date . NB In the draft recommendation for prioritization of DIBP (ECHA document ECHA/MSC-12/2010/029 (1)), 12 months is seen as the minimum time needed to prepare an application for authorization.
Likewise, maximum default application and sunset dates could be used.
Of course, pragmatic arguments related to the capacity of ECHA to process the applications for authorization (REACH article 58(3) should also be taken into account in the recommendation. 
On the basis of the information provided we see no reason to propose a differentiation in the application date or sunset date for different use categories.
We suggest to apply the shortest realistic and pragmatic possible application date.	Thank you for your comments.

ECHA developed the draft Annex XIV entries for the second recommendation based on the “Guidance on inclusion of substances in Annex XIV”. 

In the guidance, the time needed for preparation of an authorisation application is estimated to amount to 18 months (roughly 12 months worktime for drafting the application plus an additional buffer of 6 months for consulting required external expertise). Therefore, a time period of 18 months should normally be given to allow for the preparation of a well documented application for authorisation. This recommended time period has been considered for suggesting the shortest application dates. As the time interval between application date and sunset date cannot be shorter than 18 months (Art. 58), the corresponding shortest sunset dates were set to 36 months.

The anticipated workload of the agency with regard to processing of authorisation applications was accounted for by grouping the proposed substances in 3 groups and spreading the application and sunset dates over a period of six months,, resulting in a combination of application/sunset dates of 18/36, 21/39 and 24/42 months for the three groups.

The time period of 12 months after entry into force suggested as application date for DIBP derived from the fact that ECHA’s first recommendation included three phthalates with similar uses. To avoid substitution of these by DIBP, ECHA proposed to set the sunset date as close as possible to the sunset date of the already recommended phthalates. However, it was recommended to concede at least 12 months because this time is recommended in the guidance as standard time necessary to prepare authorisation applications. In the particular case of DIBP it was not deemed necessary to consider 6 further months for consulting of external expertise, as no further expertise beyond that required for the other three phthalates seemed to be necessary.

However, analysis of the anticipated entry into force of the Commission Regulation amending Annex XIV to the REACH Regulation for the first time (i.e. January 2011) suggested a revision of the dates as there presumably would be overlap between the application dates of the first amendment of Annex XIV and the second one, which will implement the current (2nd) recommendation, if this latter Commission Regulation would enter into force in January 2012. In this case there may be overlap between the application dates of the phthalates included by the first amendment of Annex XIV and the arsenic oxides of the second amendment of this Annex. This needs to be revised in order to avoid overload of the Agency and its committees with authorisation applications. As quite many applications for at least some phthalates are expected, it seems to be advisable to adjourn the application dates of the arsenic oxides by 3 months and combine those with the application dates for lead chromate and the lead chromate pigments (for these substances less applications are anticipated so that there is not so much concern of overload of the Agency by authorisation applications). There is as well not so much concern regarding overload of the Agency due to overlap of the application date for HBCCD of the first recommendation and TCEP and 2,4 DNT of the second one. Therefore this overlap seems to be tolerable.

As a different date of entry into force of the second recommendation than January 2012 would again lead to a different situation, the general proposal for amendment of the transitional arrangements is to recommend to the Commission: 
i)	Consider potential overlap of the application dates between 1st and 2nd recommendation in order to avoid overload of the Agency with authorisation applications. 
ii)	Consider the recommendation of the guidance regarding the time that normally should be given for preparing authorisation applications (18 months) as starting point for calculating the latest application dates.
iii)	Consider grouping of the substances of the second recommendation in 2 lots with a time interval of 3 months between the lots (rather than 3 lots within 6 months as originally proposed, in order to speed up the authorisation process).
	
8	2010/09/30	International NGO
WWF European Policy Office
Belgium	The timelines foreseen for transitional arrangements are too long and should be shortened 12 months application date (sunset date 30 months) to ensure better worker and environment protection as soon as possible.	Thank you for your comments.

Please see our response to comment 7.	

III - Comments on uses that should be exempted from authorisation, including reasons for that
#	Date 	Submitted by (name, Organisation/MSCA)	Comment	Response	
9	2010/09/29 	Germany	The German CA agrees with the proposal not to exempt certain categories of uses.	Thank you for your support	
10	2010/09/30 	International NGO
International chemical secretariat
Sweden	No uses need an exemption. Authorisation should cover all uses.	Thank you for your support	

IV - Transitional arrangements: comments on the proposal and conclusion
#	Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
11	2010/09/29 	Germany	The German CA agrees with the proposal not to include review periods for certain uses.	Thank you for your support