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Helsinki, 23/02/2016
Doc. CA/13/2016
20th Meeting of Competent Authorities for REACH and CLP (CARACAL)
8-9 March 2016
Room MANS, CHARLEMAGNE building
Brussels
Concerns: Update on ECHA Guidance activities
Agenda Point: Information point 9
Action requested: For information
Update on ECHA guidance activities
1. Introduction
This document provides an overview of the current status and recent developments in ECHA guidance activities, particularly of changes in status of existing projects and new projects introduced since the last report to the CARACAL in November 2015. In addition, as this is the first CARACAL meeting of 2016 some brief notes are included on the general strategy for ECHA guidance foreseen for the year ahead.
Work on guidance updates continues as foreseen in the update on guidance activities made to the 19th meeting of the CARACAL. Particular focus is being placed on updates of important documents relevant for the 31 May 2018 REACH registration deadline.
Wherever practicable the aim will be to finalise REACH guidance updates relevant to the 31 May 2018 deadline by 31 May 2016 – i.e. there will be a voluntary “moratorium” on updates 2 years ahead of the deadline. However, since it has already been identified that some updates cannot be completed by this date because the inputs necessary for drafting them were not or will not be available in time to allow full consultation, the approach to the moratorium will be based on the precise statement of ECHA’s strategy already made public in the ECHA Work programme for 2016, i.e.:
“To provide stability to duty holders preparing for the 2018 REACH registration deadline, the Agency will apply a “Guidance moratorium” from 31 May 2016 onwards. Apart from exceptional updates in response to, for instance, changes to the legal texts or alignment of the guidance with updated tools or working procedures, ECHA will not publish registration-related guidance until after the registration deadline of 1 June 2018. For guidance documents, which eventually have not been finalised by the end of May 2016, ECHA will communicate by 1 June 2016 the nature of the changes proposed and a timeline for their publication;”
Provisional publication dates for on-going guidance activities, including those with a foreseen publication date beyond 31 May 2016 are given below. As first reported to the CARACAL in November 2015, it should be noted that updates to be published later than this date notably include updates to the Guidance on Registration and to the Guidance on data sharing, to take into account recent developments such as the implementing legislation on data sharing and developments of IUCLID and other tools, including changes in implementation of the one substance one registration (OSOR) principle.
2. General issues
Work on guidance updates continues as foreseen in the update on guidance activities made to the 19th meeting of the CARACAL.
2.1 Guidance on substances in articles
As foreseen, an update of the Guidance on requirements for substances in articles was published following a fast-track consultation of the CARACAL only on 17 December 2015. This update was restricted to correcting the parts with references to the 0.1% limit that were no longer consistent with the conclusions of the judgement of the Court of Justice of 10 September 2015 in case C-106/14. A roadmap has been finalised for a further, more comprehensive update, according to the strategy outlined in the report to the CARACAL of November 2015.
2.2 New guidance/guidance updates foreseen to be initiated in 2016
In addition to the currently on-going projects already under consultation (listed in 3.2 below), the following update projects are foreseen for initiation in 2016:
1. Further update to the Guidance on requirements for substances in articles (see above 2.1) – provisional target date for publication December 2016/ January 2017;
2. Update of the Guidance on Registration (for reasons given in the introduction above) - provisional target date for publication October 2016;
3. Update of the Guidance on Data Sharing (for reasons given in the introduction above) – provisional target date for publication December 2016/ January 2017;
4. Update of the Guidance on IR&CSA, Chapter R.7.a, Section R.7.5 Repeated Dose Toxicity (specifically addressing route of administration) – provisional target date for publication Q1 2017;
5. Guidance on IR&CSA - Chapter R.11 and Part C on PBT assessment (addressing recent scientific developments in the field and outcome from the PBT Expert Group’s discussion) and PBT-related sections of IR&CSA Chapters R.7b and R.7c – provisional target date for publication May 2017;
6. New appendix to the Guidance on Registration, Guidance on nanoforms – provisional date for publication Q1/Q2 2017;
7. Update appendix to Chapter R.7a of the Guidance on IR&CSA, Information requirements for nanomaterials for human health – provisional date for publication Q1/Q2 2017;
8. Update appendix to Chapter R.7a of the Guidance on IR&CSA, Information requirements for nanomaterials for the environment – provisional date for publication Q1/Q2 2017;
9. New appendix to Chapter R.6 of the Guidance on IR&CSA, QSARS and grouping of chemicals concerning read-across for nanomaterials– provisional date for publication Q1/Q2 2017;
10. Guidance on the application of the CLP Criteria (update to take into account the 8th ATP to CLP to be published in 2016) - provisional date for publication April/May 2017;
11. Guidance on Labelling and Packaging in accordance with Regulation (EC) No 1272/2008 (additional update to the one already on-going as described in 3.2 b. below to take into account the 8th ATP to CLP to be published in 2016) - provisional target date for publication April/May 2017.
3. Other Guidance
A summary of Guidance and guidance-related documents (concerning REACH and CLP) published that have not previously been reported to the CARACAL and of the status and planning of on-going guidance activities is given hereafter.
3.1 Guidance published
The following REACH and CLP guidance updates were published during the period November 2015 to February 2016 and not previously reported to the CARACAL:
a. REACH
1. Guidance on IR&CSA - Chapter R.12 (Use Description) - published on 8 December 2015;
2. Guidance on IR&CSA, Chapter R.7b, Section R.7.8.7 to R.7.8.13 related to the Sediment compartment – published on 16 February 2016 (earlier than foreseen as no comments were received from the CARACAL consultation);
3. Guidance on IR&CSA, Chapter R.16 (Environmental exposure assessment – published on 16 February 2016 (earlier than foreseen as no comments were received from either the MSC or the CARACAL consultations);
4. Guidance in a nutshell – compilation of safety data sheets – published on 17 December 2015.
b. CLP
No new or updated guidance documents on CLP were published between November 2015 and February 2016.
3.2 Other on-going and planned guidance activities
a. REACH
The following consultations on REACH-related guidance updates are on-going:
1. Guidance on IR&CSA – Part E, Section E.2 Risk characterisation for physicochemical properties
o The launch of the written consultation of the MSC and Forum were postponed to February 2016 due to resource constraints;
o The target date for publication of the guidance update is postponed to May 2016 (previously reported as March 2016).
2. Guidance on IR&CSA - Chapter R.15 (Consumer exposure estimation)
o A second written consultation of the PEG was required (limited to the sections regarding infrequent uses) and was launched on 23 October 2015 with a deadline for comments of 13 November 2015. A total of 163 further comments were received from 6 Member States (FR, 32; DE, 55; UK, 3; NL, 19; NO, 12; DK 3) and 6 stakeholder organisations (AISE, 9; Cefic, 6; CEPE, 4; ECETOC, 5; EUROMETAUX, 8; FEICA, 7);
o The target date for publication of the final documents is consequently postponed to May 2016 (previously reported as March 2016).
3. Guidance on IR&CSA - Chapter R.7a Section R.7.3 (Sensitisation)
o The target date for publication of the guidance update for this aspect has been postponed to May 2016 (previously reported as March 2016) to allow taking into account the discussion at the REACH Committee of revision of REACH Annex VII, 8.3 in advance of the MSC/RAC consultation.
4. Guidance on IR&CSA - Chapter R.7a Section R.7.4 (Acute toxicity)
o Work is ongoing on implementing the PEG comments;
o The target date for publication of the guidance update for this aspect is now May/June 2016 (previously reported as May 2016).
5. Guidance on IR&CSA – Chapter R.14 (Occupational exposure assessment)
o The written PEG consultation was launched on 20 November 2015 with a deadline for comments of 18 December 2015. A total of 590 comments were received from 5 Member States (FR, 12; DE, 82; UK, 29; NL, 106; SE, 17) and 7 stakeholder organisations (Cefic, 67; CEPE, 14; CONCAWE, 49; ECETOC, 68; EFCC, 45; EFEO, 1; EUROMETAUX, 100). The target date for publication of the final document is July 2016.
6. Guidance on IR&CSA – Part D (Framework for exposure assessment)
o The written PEG consultation was launched on 20 November 2015 with a deadline for comments of 18 December 2015. A total of 143 comments were received from 4 Member States (DE, 2; UK,11; NL, 9 ; SE, 8 ) and 4 stakeholder organisations (Cefic, 40; CONCAWE, 33; ECETOC, 39; EFEO, 1).
o The target date for publication of the final document is July 2016.
b. CLP
1. Guidance on Labelling and Packaging in accordance with Regulation (EC) No 1272/2008
o The written PEG consultation was launched on 13 November 2015 with a deadline for comments of 11 December 2015. A total of 721 comments were received from 7 Member States (DE 178; IE 69; NL 10; NO 40; PL 15; SE 22; UK 47) and 9 stakeholder organisations (ACEA 9; AISE 10; CEFIC 14; CEPE 23; ECETOC 7; ECPA 12; EFCC 8; EFEO 1; EUROMETAUX 119);
o The target date for publication of the final document remains at May/June 2016.