Although the deal with different scenarios, the Purple and Orange Books need to keep in step. The GHS experts spend much of their time making sure they do
The UN Sub-committee of Experts on the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) held its 38th session in Geneva this past 11 to 13 December. The meeting was the second of four planned for the current (2019/2020) regulatory biennium, although the third meeting was subsequently cancelled due to the current Coronavirus pandemic.
The session was chaired by Maureen Ruskin (US) with Paul Taylor (Australia) as vice-chair. It was attended by experts from 19 countries, observers from Switzerland and Thailand and representatives from the EU, the UN Institute for Training and Research (Unitar) and 12 non-governmental organisations.
The Sub-committee heard that the English, French and Russian language versions of the eighth revised edition of GHS had already been published and that the Spanish, Chinese and Arabic versions were being prepared[although they have not, as of June 2020, appeared]
. It was also noted that the English and French language versions of the seventh revised edition of the Manual of Tests and Criteria were also available.
The first item on the agenda was to review the work of the sister UN Sub-committee of Experts on the Transport of Dangerous Goods (TDG), particularly as it relates to GHS matters. France reported on the work to improve the testing of oxidising liquids and solids, specifically the testing of materials of different particle sizes distribution and coated materials, as well as improvements to the testing methods for the Tests O.1, O.2 and O.3. Work was still ongoing, by means of round-robin testing at 13 laboratories in eight countries. At the time of the meeting, experimental data were being gathered and processed. A report on further progress will be made at the next session.
The chairman of the Working Group on Explosives reported to both sub-committees on the work of the International Group of Experts on the Unstable and Energetic Substances (IGUS) ad hoc working group on the revision of UN test series H. Changes had recently been adopted to cover polymerising substances but a broader review had been carried out to update the current test descriptions and to delete over-specification, especially in the adiabatic storage test (AST) in test H.2 and the isothermal storage test (IST) in test H.3, along with the introduction of standard heat-loss values, where possible, for packagings.
The paper included specific proposals to amend 28.1 in Section 28 of the Manual of Tests and Criteria. The authors of the proposal were reminded that they needed to take account of the applicability of the Manual of Tests and Criteria in sectors other than transport; the GHS experts were invited to send comments to Peter Schuurman at the European Chemical Industry Council (Cefic) by mid-March 2020 at the latest.
Sweden updated the GHS Sub-committee on the long-running work to revise Chapter 2.1; this work has resulted in acknowledgment of the need to extend the classification system in GHS and new criteria and associated hazard communication elements are under development. The main feature of the new classification system is that it will go further than the current reliance on product configuration, which is used in transport – that is, the classification takes account of the way the substances and articles are configured and packaged.
The proposed new classification system, while remaining largely based on the current divisions used in GHS and the TDG Model Regulations, evaluates the explosive behaviour down to the level of the primary packaging (normally the innermost container) and validates whether or not the explosive effect as reflected by the division is also accurate at that level. This removes the possible mitigating effect that the (transport) configuration may have, which can be substantial, and thereby allows for appropriate GHS hazard communication for the primary packaging.
Another feature of the new system is to provide a means to classify explosives not assigned to a division for reasons other than being too sensitive (i.e. for other than “unstable explosives”), which the current system does not. For example, in explosives manufacturing and processing there is no (transport) configuration that can be subjected to the appropriate tests for assigning a division, and hence no GHS classification can currently be assigned (unless they are “unstable explosives”). The new system is able to classify explosives also in this situation and assign GHS hazard communication elements to them.
At the 36th session of the GHS Sub-committee, it was agreed that the review of Chapter 2.1 should be completed during the current biennium. The criteria for the various classifications within the new GHS system are now essentially finalised but the question of whether an exclusion should be made for substances and mixtures in the research and development phase has not been fully resolved. There is also the issue of how to deal with those substances, mixtures and articles that are excluded from Class 1 in the TDG Model Regulations and assigned to specific UN numbers in the Dangerous Goods List, but which fall under the GHS criteria for explosives. Guidance is now being developed on the application of the criteria via correspondence and teleconferencing.
Work was also progressing on the assignment of appropriate hazard communication elements and precautionary statements. A draft of the new Chapter 2.1 had been circulated for discussion and comment and its was expected that this would be finalised before the next sessions of both the GHS and TDG Sub-committees.
The UK and the Netherlands gave an update of discussions by the informal working group on the use of non-animal testing methods for classification of health hazards, which had earlier focused on a review and possible revision of either Chapter 3.3 on serious eye damage or Chapter 3.4 on skin sensitisation. As part of the Chapter 3.3 review, the informal working group will consider again the specific issue of classification using pH values, especially where the appropriate classification is corrosive or inconclusive. The work has also been bolstered by the participation of the European Commission’s Joint Research Centre (JRC), which created a first revised draft of Chapter 3.3. This had already been discussed by the informal working group and the draft will be further refined.
The Sub-committee acknowledged the work done by the informal working group and noted that a proposal will be submitted to the next session for consideration.
The US provided an update on the work of the informal correspondence group looking at practical classification issues, following on from a thought-starter from the International Association for Soaps, Detergents and Maintenance Products (AISE) and Croplife International presented at the previous session, relating to the cut-off value/concentration limits for mixtures presenting a hazard of serious eye damage.
The group had also looked at the relationship between acute toxicity and specific target organ toxicity and was continuing to develop examples that it planned to present in a working document for the next session. On the concept of applying additivity to health hazard classes for which additivity is not explicitly mentioned, there was general agreement within the informal group that references to substances of unknown or variable composition, complex reaction products and biological materials and multi-constituent substances should be removed from the proposed text. The group also agreed to separate the text into a more concise description for Chapter 1.3 and to provide additional guidance. Discussions will continue with a view to finalising proposals at the next session.
Another upcoming issue for the Sub-committee will be the development of a suitable viscosity criterion for the classification of mixtures for aspiration hazards. The representative of the International Paint and Printing Ink Council (IPPIC) informed the Sub-committee that work on this topic is ongoing.
The expert from France, on the other hand, reported that work on nanomaterials has stalled and that France was no longer in a position to continue to lead the work without the help of other delegations. A general call for help was put out, with the promise to report back at the next session.
Progress has, however, been made by the informal correspondence group on the simultaneous classification in physical hazard classes and the precedence of hazards, as the TDG Sub-committee had already heard. One important element currently being worked on is the safety of testing personnel, bearing in mind the possibility that testing might become more hazardous if substances with certain properties are being tested. There are also some cases where classification tests cannot be carried out: liquids cannot be subjected to Test N.4 for self-heating substances and mixtures as that involves heating the sample in a mesh container; and pyrophoric liquids cannot be tested for their flash point as ignition occurs more or less immediately.
During a short meeting alongside the Sub-committee’s session, the group noted that the Manual of Tests and Criteria already provides advice on the possibility to test with smaller amounts. It was agreed that this advice would be compiled into a single document for consideration by the group.
Another interesting point raised by Germany in its report on progress was the possibility that hazard communication may give the wrong message. For instance, it quoted the case of explosives that burn normally when ignited and may have a burning rate that meets the criterion for classification as a flammable solid; these would be accompanied by hazard communication indicating a flammable solid as well as an explosive, whereas explosives that react violently rather than burn would only be classified as explosive.
This raised the idea that the problematic tests might benefit from amendment, although the Sub-committee agreed that this did not fall within the scope of the group’s work.
ALIGNMENT AND CORRECTIONS
The Secretariat had prepared a paper outlining some potential corrections and clarifications to the GHS document. Firstly, it noted that it currently refers inconsistently to the UN Recommendations on the Transport of Dangerous Goods, the Model Regulations and other variations on the same theme. It proposed that the definition in Chapter 1.2 should refer to the UN Model Regulations, and that this term should be standardised as such throughout GHS. This suggestion was adopted.
The Secretariat also noted that the criteria in the tables of each chapter of Parts 1 to 4 are normally identified by letters, partly to avoid confusion with the numbering used to identify classification criteria. This principle is applied consistently throughout GHS, except for tables 2.3.1 and 3.2.2, which used numeric indicators. A proposal to align them was also adopted.
The Secretariat had also been advised of a printing error in Annex 7, example 10, where the words ‘Read full label enclosed’ are missing in the illustration. The US said it would prepare a formal proposal to amend this at the next session.
The Secretariat noted that the presentation of the decision logics is becoming problematic as a result of software updates; until recently it has managed to work around these issues but some are now being printed with errors. It alerted the Sub-committee to the intention to convert the decision logics into a format compatible with the latest version of the text processing program, which may result in changes to the current design. One delegation asked for these to be submitted in an official document for the next session, although the Secretariat indicated that there may not be time to have this ready.
The Secretariat further provided a paper with corrections to the eighth revised edition of GHS, which were all adopted by the Sub-committee.
China had already made a proposal to the TDG Sub-committee to amend 126.96.36.199.3.4 of the Model Regulations, dealing with the classification of the chronic aquatic environmental hazards of mixtures, which had been paraphrased from section 4.1.3 of GHS. The debate had been inconclusive and experts had been invited to submit comments to China in writing so that a revised proposal could be made. China also proposed similar clarification to 188.8.131.52.4 of GHS, with the same result. A formal proposal was to be made at the next session.
Australia proposed some clarifications to the classification criteria for eye irritation Category 2 in Chapter 3.3 of GHS, after experiencing confusion during its implementation of the seventh revised edition. Its paper had already received some comments and corrections, and the US came up with further amendments offering an alternative approach.
GHS currently refers to Category 2, 2A and 2B; Australia felt this was confusing and that Category 2 should be accompanied by two Sub-categories, 2A and 2B. There was agreement that this was a sensible change and, indeed, that it should be followed elsewhere in GHS.
There is clearly more work to be done on this and Australia, Germany and the US volunteered to work together to develop a proposal for consideration at the next session.
On behalf of the informal working group on practical labelling issues, Cefic followed up on Unitar’s earlier proposal to revise examples 1 to 7 in Annex 7; it was agreed that some examples need to be updated since they are no longer in line with the latest edition of GHS. Several options were offered. The Sub-committee agreed that the examples should be updated but that the layout should be retained, while reference to explicit chemical names should be deleted. It was also agreed that explicit labelling examples would be included in the guidance on the GHS web pages.
Cefic also presented as a thought-starter the results of discussions involving a number of non-governmental organisations on the opportunities that the digitisation of hazard information may bring to the conveyance of hazard information. The use of digital means to address hazard information for chemicals is increasing worldwide and offers significant advantages in terms of a more targeted and effective hazard communication. However, no global standards are currently available covering hazard labelling of chemicals. Furthermore, consumer research has indicated that current GHS labelling may not be fully effective in conveying safe use and hazard information to the general public, especially on small packaging or when multiple languages are required.
It is felt that a digital label could address many of the shortcomings of physical on-pack GHS labels, while providing additional support to vulnerable members of society. In the workplace, it would be sensible to link the GHS hazard label to the relevant safety data sheet (SDS). Digitising the label would also allow hazard information to be updated very quickly.
While all this sounds positive, there are potential issues: the relevant technologies are not available to all consumers; there are privacy and data security concerns; and GHS does not currently address digital labels and would need amendment. The paper did not propose to replace the physical label, which should be kept; digital transmission of information should complement the on-pack hazard communication.
The Sub-committee was invited to share any existing experiences at the national level and the informal working group was invited to discuss further the challenges, issues and drawbacks of the proposal.
The UK reported on behalf of the informal working group on improving Annexes 1, 2 and 3 of GHS with a lengthy paper proposing amendments to the tables and notes in Annex 1 with the aim of removing inconsistencies, improving clarity and enhancing the readability and presentation of the tables. One aspect of the proposal was to include the corresponding transport label alongside the GHS pictogram(s) in the table. With some amendments, the Sub-committee adopted all the proposed changes.
A supplementary paper from the UK, again on behalf of the informal working group, contained some suggestions for correction and amendment of Annex 3, sections 2 and 3. These again were adopted, with the heading of the tables for eye damage/irritation in Chapter 3.3 of Annex 3 changing from ‘EYE DAMAGE/IRRITATION’ to ‘SERIOUS EYE DAMAGE/EYE IRRITATION’. In the tables for pyrophoric liquids in Chapter 2.9 and pyrophoric solids in Chapter 2.10, under ‘Prevention’, P231, relating to the use of inert gas, the following is inserted:
Manufacturer/supplier or the competent authority to specify appropriate liquid or gas if “inert gas” is not appropriate.
In Table A.3.2.2, Section 2, for the P230 entry, the precautionary statement “Keep wetted with…” is replaced by the precautionary statement “Keep diluted with…”. A similar change is made in Section 3 for the P230 entry.
The informal working group on improving Annexes 1, 2 and 3 is continuing with its tasks, with its work plan including hand-eye contact and a review of combination statements in Annex 3. Its discussions on hand-eye contact have raised the issue of other areas of skin or clothing that may also be contaminated with an eye irritant; it expected to bring forward a proposal at the next session.
The Secretariat had been looking at the use of acronyms and abbreviations in GHS and felt that these should be grouped in Chapter 1.2. This was agreed by the Sub-committee, as were proposals for new definitions for ‘Aerosols (aerosol dispensers)’, ‘Chemicals under pressure’ and ‘Gases under pressure’.
Australia and Canada had noticed that references to the heading of section 9 of the safety data sheet are not presented consistently throughout GHS, with alternatives including ‘Physical and chemical properties’, ‘Basic physical and chemical properties’ and ‘Physical and chemical properties and safety characteristics’, the latter being the formal title of that section. To provide consistency, it was proposed that all these be changed to ‘Physical and chemical properties’, an idea that was adopted by the Sub-committee.
The US and Canada provided an update of the work of the informal correspondence group on the development of a global list of chemicals classified in accordance with the GHS, whose first two work streams are to identify existing lists that implement the GHS and compare them with the guiding principles set down to ensure that classifications are developed transparently, with stakeholder input, from publicly available and electronically available data, and be non-binding.
The Swedish Chemicals Agency had been in the process of commissioning a study that would cover these items; however, it learned that Cefic had gathered information on the implementation of GHS in specific countries and had compiled this information into a report, which was also presented at this session. Sweden’s study has therefore not gone forward.
The informal correspondence group was encouraged to go forward with its work and to report back at the next session.
Cefic reminded the Sub-committee that its project had included a template of information to be gathered from different countries and shared the results of its labours so far, inviting comments from the experts. It was suggested that an additional column be added addressing the implementation of cut-off values for mixtures. A further update will be provided at the next session.
The EU informed the Sub-Committee that a legal proposal to implement the provisions of the sixth and seventh revised editions of GHS with regard to safety data sheets was under discussion and it was expected to be adopted for entry into force by mid-2020.
The Secretariat of the ANDEAN Community (comprising Bolivia, Colombia, Ecuador and Peru) advised the Sub-committee that the updated Technical Manual for the Registration and Control of Chemical Pesticides for Agricultural Use had recently been updated; it aligns with GHS in many of the building blocks under physical, health and environmental hazards, and also requires safety data sheets in accordance with GHS.
New Zealand’s Environmental Protection Agency opened a public consultation in October 2019 with the aim of updating its classification framework (implemented in 2001) to the seventh revised edition of GHS, with the aim of issuing a new EPA Classification Notice incorporating GHS by reference.
Both Canada and the US reported that they were in the process of aligning with the seventh revised edition of GHS, with the US expected to complete the transition during 2020.
The Organisation for Economic Cooperation and Development (OECD) provided a review and update of references to OECD guidance documents and test guidelines in GHS and a lengthy proposed list of amendments to Chapters 3.2 and 3.5 of GHS. These were deemed acceptable and were adopted without change.
The Secretariat had also been looking at the various references to external standards and guidelines in Annexes 9 and 10 and offered two options for keeping up with revisions, cancellations and new publications, feeling that a systematic approach was needed. Opinion was divided on which option was preferable and the Secretariat was invited to prepare an official document for the next session.
The Secretariat also updated the Sub-committee on the work of the Expert Working Group on the review of the Annexes to the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal. That Group had focused work recently on alignment with GHS, ADR and the UN transport classification system. Further work is ongoing.
The Secretariat further reported on the recent work of the International Conference on Chemicals Management (ICCM), which had begun looking at its strategic approach post-2020. ICCM mentions GHS several times as the international standard for classification and labelling and its level of implementation is used as one of the indicators of the implementation of the Strategic Approach to International Chemicals Management (SAICM). The Sub-committee was invited to encourage governments and non-governmental associations to provide regular updates on the status of GHS implementation around the world, as this will become increasingly valuable to countries implementing GHS for the first time or for those updating their legislation to more recent editions.
The International Petroleum Industry Environmental Conservation Association (IPIECA) had been working a revision of its GHS guidance, last published in 2010, to ensure that it reflects current research and scientific developments and is consistent with the latest versions of GHS in relation to the application of its criteria to petroleum susbtances. The Sub-committee was presented with a second edition of this guidance, updated to the seventh revised edition of GHS. It was invited to link to the updated guidance on the UN GHS website under Section 2 (sector-specific guidance) of the GHS guidance.
The International Council of Chemical Associations (ICCA) provided an update on its work in the areas of awareness raising and capacity building. During 2019 it had been working with Germany’s Federal Ministry for the Environment on GHS implementation in Côte d’Ivoire and Ghana, and also held workshops and meetings in Hanoi, Buenos Aires and Oman to discuss GHS implementation. ICCA said these activities would continue in 2020.
The 39th session of the GHS Sub-committee, originally scheduled to take place from 8 to 10 July, was postponed because of the Covid-19 crisis; it is now scheduled to take place from 9 to 11 December 2020.[post_title] => GHS: Testing, testing [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => ghs-testing-testing [to_ping] => [pinged] => [post_modified] => 2020-06-18 07:54:01 [post_modified_gmt] => 2020-06-18 06:54:01 [post_content_filtered] => [post_parent] => 0 [guid] => https://hcblive.com/?p=22768 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw )
Although the deal with different scenarios, the Purple and Orange Books need to keep in step. The GHS experts spend much of their time making sure they do