ENVIRONMENT DIRECTORATE-GENERAL
Water, Marine Environment & Chemicals
Chemicals, Biocides and Nanomaterials
ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL
Resources Based, Manufacturing and Consumer Goods Industries
REACH
Chemicals Industry
Brussels, 1 March 2013
Doc. CA/10/2013
12th Meeting of Competent Authorities
for REACH and CLP
13 - 14 March 2013
Concerns: UNSCE GHS – Overview on activities
Agenda Point: 16
Action Requested: For information and discussion.
The present paper provides a summary of the outcome of the meeting of UNSCE GHS in December 2012 (part I), as well as information on the Subcommittee's work in biennium 2013/2014 (II).
EU coordination meeting
An EU coordination meeting took place in the morning of 12 December 2012, i.e. just before the start of the official meeting.
Based on the paper provided to the CARACAL meeting in November 2012 (CA/67/2012) views were exchanged on amendments to the GHS likely to be endorsed by the UN SCE GHS during its 24th session
The UK presented an updated proposal on the GHS pictogram codes for sectors other than transport (UN/SCE GHS/24/INF.19), which had been submitted following the discussions at CARACAL. The new proposal was supported by all Member States experts.
Both, the proposal from France on reviewing the applicability of the GHS to manufactured nanomaterials as well as the one from Ireland on the requirement to include the transport pictograms in section 14 of the Safety Data Sheet did not find support by all other EU Member States representatives. Unfortunately, no representative from France was present at that meeting to provide further background to its proposal.
The Commission noted that both proposals had been submitted without prior consultation among the Member States, which could have avoided this situation. It announced that it would present a paper to the next CARACAL meeting on how to improve consultation for paper prepared and submitted outside Informal Correspondence Groups (ICGs).
I. Outcome of the 24th session of the UN SCE GHS (12 - 14 December 2012)
Participants
Experts from 12 EU Member States participated in the meeting of the SCE GHS, as well as experts from Argentina, Brazil, Canada, China, Japan, Norway, Qatar, Republic of Korea, Russian Federation, South Africa, the USA, and Zambia.
In addition, observers from Chile, Philippines, Romania, Slovakia and, Switzerland, representatives from UNITAR, OECD, IMO, WHO and 15 non-governmental organisations including Industry associations were present, as well.
A large part of the preparatory work discussions of the subcommittee had taken place in meetings of the so-called informal correspondence groups (ICGs):
§ ICG on hazard communication in the supply and use sector for substances and mixtures "Corrosive to Metals"
§ ICG on practical classification issues
§ ICG on the labelling of small packagings
§ ICG on the Development of a list of chemicals classified in accordance with the GHS
§ ICG on the revision of section 9 of Annex 4 of the GHS (SDS)
Reports from the various ICGs were provided during the plenary meeting of the SCE GHS at the various related agenda items.
Proposals for updating of the GHS
1) Recommendations made by the SCE at its 21st, 22nd and 23rd sessions
The SCE confirmed the decisions taken at it previous sessions regarding
· a new sub-section in chapters 3.2 (Skin corrosion / irritation) and 3.3 (Serious eye damage / eye irritation) in order to provide guidance on how to classify based on existing data from studies with 4 or more animals. So far, the GHS does not specify how to classify based on existing data from tests with more than 3 animals; and
· some new / revised decision logics in Part 2 (Physical hazards)
2) A number of editorial changes / corrections / amendments were adopted
· Corrections to figure 2.1.3 in chapter 2.1 ("Explosives") (replacing "substance" with "substances/mixtures"
· Corrections to chapter 2.3 (aerosols)
· Corrections to chapter 2.8 (self-reactive substances and mixtures)
· Various corrections in the French version of the GHS
· Amendments to physical hazard precautionary statements (The UK submitted a proposal on behalf of the relevant ICG, in which amendments for around 50 precautionary statements and combinations of precautionary statements in Annex 3, section 3 of the GHS - "Use of precautionary statements" were proposed)
· A revised annex, combining the information presented in Annexes 1 ("Allocation of Label Elements") and 2 ("Classification and Labelling Summary Tables") of the GHS
· GHS pictogram codes for sectors other than transport as presented in the revised UK paper and in line with the numbering already used in the CLP Regulation (UN/SCE GHS/24/INF.19)
· Alignment of the terminology used in Chapter 4.1 ("Hazardous to the Aquatic Environment")and Annex 9 ("Guidance on Hazards to the Aquatic Environment") due to the update of the criteria for aquatic hazard to include classification based on chronic toxicity in the 3rd revision of the GHS
· Following an OECD Council Decision to delete several OECD test guidelines (the test guidelines are no longer used in practice by regulatory authorities and better test guidelines are available for the same hazard classes), certain references needed to be updated in various chapters of the GHS
3) Alternative test methods for oxidizing solids
Both the SCE GHS and the SCE TDG agreed to include this alternative test method in the manual of Tests and Criteria.
Hazard communication issues
· Work of the ICG on hazard communication in the supply and use sector for substances and mixtures "Corrosive to Metals"
At its twentieth session in December 2010, the Sub-Committee agreed the following competent authority option in paragraph 1.4.10.5.5 (Special labelling arrangements) of the GHS to address potential issues which may arise if the physical hazard ‘Corrosive to Metals’ is adopted for supply/use situations:
“Where a substance or mixture is classified as corrosive to metals but not corrosive to skin and/or eyes, the competent authority may choose to allow the hazard pictogram linked to corrosive to metals to be omitted from the label of such substances or mixtures which are in the finished state, packaged for consumer use.”
Some delegations considered this amendment to be a temporary solution. As a consequence, an ICG had been established to develop a permanent solution in the biennium 2011 – 2012.
Five options for a permanent solution plus associated GHS amendments were presented in the related working document.
Neither in the SCE GHS nor in the SCE TDG consensus was reached on any of the proposed options. Those who expressed a preference favoured option B (Replace the corrosion symbol with a new corrosive to metals only symbol). However, concerns were also raised to introduce a new pictogram at this early stage of GHS implementation.
The ICG concluded
o That the work on this issue should be stopped for the time being
o That the temporary solution should be maintained and
o That the issue could be reconsidered again, once experience and information on consumer understanding of the labelling have been gathered.
· Inclusion of transport pictograms in Section 14 of the SDS
Ireland had submitted a proposal to include a new sub-paragraph in Annex IV of the GHS ("Guidance on the Preparations of Safety Data Sheets") in Section 14 ("Transport Information") in order to attain consistency in the hazard communication elements for supply and transport displayed on a label and in a SDS.
There was some support for the proposal. However, taking account of the concerns expressed by some delegations, the SCE GHS considered that the proposal needed to be further developed and entrusted its considerations to the ICG on practical classification issues for the next biennium.
· Work of the ICG on dust explosion hazards
The USA on behalf of the informal correspondence group (ICG) on dust explosion hazards proposed editorial amendments in Section 2 (Hazard identification), 5 (Fire-fighting measures) and 7 (Handling and storage) of the SDS guidance in Annex IV.
Changes proposed just before the meeting of the SCE GHS by the chair of the ICG were not endorsed by the ICG itself, apart from small changes in section 2. The discussion will continue in the biennium 2013 – 2014.
· Work of the ICG on the labelling of small packagings
According to the Mandate / Terms of Reference, the task of this ICG was amongst others to develop guidance on the application of the general principles for the labelling of small packagings.
During the biennium 2010-2012, after considering that developing guidance on the application of the general principles for the labelling of small packagings was premature, the ICG drafted illustrative examples on how the general principles for the labelling of small packagings described in paragraph 1.4.10.5.4.4 ("Labelling Procedures") of the GHS may be applied.
Five examples were developed as illustrations of the application of the general principles. However, no agreement could be reached in the ICG on the publication of these examples (e.g. in an annex to the GHS or on the UNECE secretariat’s website).
The SCE GHS acknowledged the work done by the ICG so far and endorsed the following tasks as proposed by the ICG for its work during the next biennium:
o Work will focus first on the development of one example illustrating the general principles applicable to the labelling of small packagings
o Once the group had reached agreement on one example it may consider one more example illustrating a more complex case.
· Reports on the status of implementation
Canada, Switzerland, the EU, Brazil, Japan, the Philippines, China, South Africa, and Zambia reported about progress made on the implementation of the GHS.
· Alignment of the Convention on the Transboundary Effects of Industrial Accidents with the GHS
The Conference of the Parties to this Convention had started work to align Annex I to the Convention with the 4th revision of the GHS. The alignment aims at ensuring consistency between the Convention and the provision of Directive 2012/18/EU (SEVESO Directive). The experts of the SCE GHS were invited to share their experience with the colleagues responsible for the Convention for this work.
· Work of the joint TDG-GHS working group on corrosivity criteria
Based on the outcome of the discussions at the last meeting of the joint TDG-GHS working group (23rd session of the SCE GHS) a proposal was developed for the 24th session to harmonise chapter 2.8 of the Model Regulations with GHS. However, in view of diverging views the group decided that it was too early for the development of detailed amendments. The work will continue during the next biennium.
· Work of the ICG on the revision of Section 9 of the SDS
The ICG had developed an INF document for the meeting, which amongst other provided a table in Annex I with the basic physical-chemical properties as well as guidance for each of the required properties by giving information on the applicability of the property and by indicating what type of information is expected in the SDS. A second Annex contained the same Table as the first Annex and is amended by justifications for each of the listed properties in order to facilitate the understanding and possible decisions to be taken by the Sub-Committee in the future.
The SCE considered that the text developed in the tables as well as the introduction needs further refinement. In addition, other (non-basic) safety characteristics which are not directly related to physical hazards classification such as auto-ignition temperature or decomposition temperature need to be developed in the ICG. Therefore the work of the ICG will continue during the next biennium.
· Work of the ICG on Practical Classification Issues
According to the Mandate / Terms of Reference, the task of this ICG was defined as to "clarify application of the GHS criteria through, for example, development of proposals for changes to the GHS document or development of examples illustrating application of criteria and any related hazard communication issues, as needed."
The ICG has developed several editorial changes to the GHS and worked out examples to be included in UNITAR's advanced course on the GHS.
The worked examples have been developed to illustrate the following issues:
(i) The use of the bridging principle interpolation within one hazard category;
(ii) Classification of a mixture following the tiered evaluation approach in GHS Chapters 3.3 ("Serious Eye Damage / Eye Irritation");
(iii) Application of mixture classification criteria for hazardous to the aquatic environment.
These worked examples were approved, and will be included in the training program of UNITAR.
Taking into account that the training courses are not publicly available, most experts expressed their wish that the examples should be made available on the GHS website, in order to be used for training courses at national level.
· Work of the ICG on the development of a global list of classified chemicals list according to the GHS
The following guiding principles to establish a global list as proposed by the ICG were adopted with some editorial changes by the UNSCE GHS:
(a) The development of a global list is compatible with the GHS principle of self-classification since the list will be non-binding (see sub-paragraph (f) below). The process for developing and maintaining a global list must be clear, transparent and follow the principles of the GHS. Opportunities should be provided for stakeholders, to provide input as well as mechanisms for expert review, conflict resolution and updating the list when new significant data or information becomes available.[1]
(b) All GHS hazard categories and classes must be included in the global list of classified chemicals.[2]
(c) Only substances, as defined by the GHS, will be included on the global list of classified chemicals;
(d) All substances must be accurately identifiable and described for each entry (e.g. including CAS numbers, the UN numbers assigned under transport of dangerous goods regulations where assigned/applicable, and relevant impurities).
(e) The data sets forming the basis for the chemical classification must be referenced with the classification. The source of the information must also be electronically available, and publicly accessible. The data should be derived using internationally recognized test methods and classification should be based on sound scientific principles.