Dr Reach - Let’s have a public airing of CLP questions to authorities

Questions are beginning to surface on the recently adopted Classification, Labelling and Packaging Regulation (CLP). In particular, industry faces submitting potentially millions of classification and labelling (C&L) notifications to the European Chemicals Agency (ECHA) by 1 December 2010.

C&L notifications were initially part of REACH. This process was then incorporated into CLP, particularly as the requirements concern the implementation of the UN Globally Harmonised System.

Specifically, notifications must contain both the classification of substances according to Directive 67/548 and the new GHS. These two systems essentially operate in parallel, with various phases being applied to mixtures.

CLP rivals REACH in terms of complexity, partly due to the interaction between the two pieces of legislation. For instance, C&L notifications apply to substances subject to registration. However, unlike REACH, substances in final form of cosmetic products are excluded from CLP.

Only Representatives

As a REACH expert and relative novice to CLP, I am struck by some potential anomalies and inconsistencies. Starting with fundamentals, the role of Only Representatives under CLP seems unclear to me.

Based on the legal preamble to CLP, I would assume that importers covered by Only Representatives should be regarded as downstream users. Therefore, should the Only Representative be considered as an importer?

Should this not be the case, then perhaps the Only Representative should act on behalf of the importers it covers as part of a ‘group’ notification. Under this scenario, technically each importer may need a REACH-IT generated ‘universal unique identifier’ (UUID) – if a UUID for each relevant company is indeed required in a ‘group’ notification. But hopefully this is not the case.

Another answer to a basic point that eludes me concerns whether notifications by other companies must be submitted after a substance has been registered. I expect the answer is yes. Similarly, I am unclear as to whether the term manufacturer only relates to the manufacturer of the substance subject to a notification or covers all substances it trades.

C&L notifications form a small part of CLP. But the practical operations are critical.

Just like REACH, CLP refers to placing on the market. Again, the Blue Book definition from the New Approach Directives of placing on the market as ‘first supply’ in a supply chain has not been adopted.

Late nights ahead

A larger number of companies and substances are touched by CLP than REACH. This number is magnified because for hazardous substances there is no one tonne threshold , and there are not the same exemptions for R&D or medicinal products.

Consequently, REACH-IT must brace itself for a potential deluge of notifications coinciding with the first registration deadline. And companies/consultants must prepare for a second round of hair-wrenching late nights backed by early mornings.

The wider aspects of CLP may however assist with implementing REACH.

I do believe that requiring detailed consideration of the substance identity should facilitate registrations – when well-managed. With this in mind, some educational and communication efforts may be needed by ECHA, Member States, industry groups and other stakeholders on the ABCs of classification!

Differentiation can occur between definitions of a substance for the purpose of data-sharing for registration and actual registration dossier submission. For instance, a joint dossier may have a particular substance definition, which other registrants may deviate from, even if part of the same joint dossier. Remember – every company must submit its own Annex VI registration dossier.

Each substance must be appropriately classified; this is not a new requirement. And classifications may vary, for example due to differences in purity. Nevertheless, differences in a classification may not necessarily prevent a sameness of substance for the purpose of a Substance Information Exchange Forum and related activities such as data-sharing and joint registrations.

Unfortunately these principles are often misunderstood or overlooked. In practice, a variety of different strategies facilitate these processes, applied on a case-by-case basis. Activities and data necessary for C&L notification dossiers should therefore catalyse SIEF and registration processes.

I attended the European Commission stakeholder meeting on CLP this month. On my Chemical Watch web forum I shall certainly report any clarifications on practical issues that I come across.

Mechanism needed

In addition to the forthcoming guidance on CLP, a series of technical FAQs on CLP would be welcome. But based on my experience with REACH so far, I think a mechanism for stakeholders to view issues that are already being considered would be particularly helpful.

Too often, it is unclear which questions have been raised and are being discussed – whether at the Commission, ECHA or at Competent Authority meetings. By having these formally and transparently listed, a combination of insight and foresight may be provided to a wider set of stakeholders.

Otherwise, it can be a case of depending on an answer to be published, in order to know that the question exists.