Last reviewed 31 August 2016
In this article, we consider how new classifications are added to Annex VI of Classification, Labelling and Packaging of Substances and Mixtures (CLP), and existing harmonised classifications updated, and how can companies keep up to date with and input into the process.
The 9th Adaptation to Technical Progress (ATP) to CLP has just been published, amending existing and adding new harmonised classifications to Annex VI, and a draft 11th ATP with further changes to Annex VI has just been notified to the World Trade Organization (WTO). In the light of these amendments, readers may be wondering how these changes are agreed by the regulators, and how they can keep up to date with and influence future changes.
The process starts with the identification of substances for which it is considered that a new harmonised classification is required, or an existing harmonised classification needs updating to reflect new information about its hazards. Such substances may come to the attention of the regulators through a variety of means, such as the evaluation process under REACH; national initiatives in a Member State; activities by regulators in other jurisdictions that identify a significant new hazard; or activities by international organisations such as the International Agency for Research on Cancer (IARC).
Substances that are on the regulators’ radar for possible action may be added to the Public Activities Co-ordination Tool (PACT), and a list of substances under consideration can be found on the European Chemicals Agency (ECHA) website. Once identified, a hazard assessment will be carried out by a Member State or ECHA, and if appropriate, a Risk Management Options Analysis (RMOA). An RMOA can conclude that regulatory risk management at EU level is required for a substance (eg harmonised classification and labelling (CLH), Candidate List inclusion, restriction, other EU legislation) or that no regulatory action is required at EU level. A report explaining the proposed action is included on the PACT-RMOA database.
If the RMOA concludes that CLH is the appropriate regulatory action, a notification of the intention to propose a CLH for the substance will be added to the Registry of Intentions. The notification submitted will indicate which Member State intends to compile and submit a dossier supporting the proposed harmonised classification, which hazard endpoints are proposed to be harmonised, and the intended date of dossier submission. For the majority of substances, CLH proposals will focus on those properties deemed to be of greatest concern, particularly carcinogens, mutagens, reproductive toxins (CMRs) and sensitisers. Due to resource limitations, substances are not normally fully classified for all endpoints, with the exception of biocidal active substances and plant protection products, for which there is a different process.
Under CLP, companies (manufacturers, importers, downstream users) may also submit proposals for new harmonised classifications, or new endpoints for existing harmonised classifications, provided that they are willing to prepare the necessary dossiers and pay the appropriate fee. Companies cannot, however, submit proposals to update existing harmonised classifications. In this case, they must liaise with the Member State competent authority where the substance is placed on the market and work with them to submit a proposal to update the harmonised classification.
Although no formal consultation takes place at this point, companies may get in touch with the relevant Member State (or company) to find out more about the issues, or to offer to share data if they have new studies available, etc.
The Member State (or company) then prepares and submits the dossier proposing the harmonised classification in the required Annex XV format. (For those wondering why it is Annex XV when CLP has only seven annexes, the format is specified in Annex XV of REACH and is used also for identification of SVHC as well as CLH.)
Once the dossier is submitted, the clock starts ticking and the process to adopt an opinion on the proposal must be completed within 18 months. The first step in the process is for the dossier to undergo an accordance check by ECHA to ensure that it is in the appropriate format and contains the required information. Once accepted, ECHA will initiate a 45-day public consultation period during which anyone can submit comments on the proposed classification.
Open consultations can be found at www.echa.europa.eu, and clicking on the “details” tab gives access to the prepared dossier as well as a link through which comments can be given. Comments may provide new or additional data about the substance that is not considered in the dossier, a different analysis of the data in the dossier, information about unintended downstream consequences of the proposal, or anything else that the commenter considers relevant.
Once the consultation period closes, the substance is moved to the “previous consultations” list and any comments received are made public and may be viewed. If they do not wish to be identified, the person commenting has the option to request that his or her name/the name of his or her organisation not be made public if he or she does not wish to be identified.
After the end of the consultation, the dossier submitter is invited to respond to the comments received, and these comments and responses are then forwarded to the Risk Assessment Committee (RAC) to develop a scientific opinion on the proposed classification. The RAC will evaluate the dossier, and the comments received, and may decide that they agree with the proposed classification, they may decide that a different hazard category is more appropriate, or they may decide that the available evidence does not support classification for that hazard class. Once the RAC has adopted its opinion, the opinion is published on the ECHA website together with a background document containing the information from the Annex XV dossier, and the responses to comments received in the public consultation from both the dossier submitter and RAC (RCOM).
The RAC opinion is then forwarded to the European Commission for consideration. If the Commission finds the opinion appropriate they will include the new or amended classification in the next ATP updating Annex VI of CLP. Once adopted into CLP, the new or amended harmonised classification becomes mandatory for all companies to use once the deadline in the ATP has passed.
As can be seen from the above description of the CLH process, there are plenty of opportunities for companies to make themselves aware of substances that may be targeted for development of a harmonised classification, and to track and input into the process. For those not wishing to check the various ECHA databases themselves on a regular basis, plenty of services exist to alert you to changes to them. These include ECHA’s own news alert service, the REACH and CLP news bulletin provided by the HSE, trade associations, and commercial service providers such as Croner. Overall, the process typically takes several years to complete, including time taken to identify hazardous substances and carry out a RMOA, 18 months from dossier submission to adoption of an RAC opinion, and then time for the Commission to include the new classification in an amendment to CLP, which will typically have a further 18-month transition period before it becomes mandatory. There should not, therefore, be any nasty last minute surprises.
Of course, companies do not need to wait for the end of the transition period in the ATP to CLP to adopt new harmonised classifications. Indeed, if companies are aware of new scientific information that a substance should have a different classification, they are obliged to review this and adapt their classifications accordingly without undue delay (CLP Article 15). Depending on the evidence presented, companies may feel it appropriate to update their classifications after reviewing the evidence made available at consultation or after adoption of an opinion by the RAC, rather than waiting for Annex VI of CLP to be amended.