On 4 May 2021, the European Commission (“the Commission”) published two important roadmaps to revise two of the main instruments comprising the existing EU chemicals legislation, these being the Classification, Labelling and Packaging Regulation (“CLP”) and the EU Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (“REACH”). The roadmaps can be accessed here. These revisions form part of the EU’s Chemicals Strategy for Sustainability (“the Chemicals Strategy”) to achieve the EU Green Deal’s zero pollution ambition for a toxic-free environment.
The draft revisions are expected to take until 2022 to be published, with the objective to improve the protection of people and the environment against hazardous chemicals in line with the Green Deal’s ambitions. Equally, the EU wishes to seize this opportunity to cement its status as a global leader in chemicals production and use. However, questions remain as to the exact scope of the revision plan for both of these pieces of legislation. A brief overview of the plans for both is set out below.
The Commission believes that the CLP has failed to keep up with scientific or technical progress, as well as with market developments. Equally, the Commission points to what it sees as the currently ambiguous nature of some of its provision. The Commission is concerned the current Regulation is unclear on hazard identification, classification or the roles of different actors which can lead to insufficient information on hazards being available.
Some of the proposals for revision, therefore, include:
- Introducing new hazard classes (e.g. endocrine disruptors);
- Adding labelling obligations for products for hazard classes currently outside the scope of the CLP;
- Clarifying the obligations to classify mixtures and some complex substances;
- Introducing specific rules for the roles and responsibilities of the various actors involved in online sales;
- Introducing the possibility to submit proposals for, and set, harmonised environmental and safety values for some substances;
- Allow multilingual fold-out labels;
- Introduce new tailored more flexible labelling rules where there is not enough space on packaging;
- Introducing a mandate for the Commission to request ECHA to develop new harmonized classification and labelling (‘CLH’) dossiers.
In its inception impact assessment, the Commission points out, among other things, that REACH still has knowledge gaps for many substances preventing a thorough hazard assessment, despite being arguably the most advanced chemicals knowledge base globally. Equally, the Commission believes that registrants’ safety assessments do not currently take combination effects of chemicals into consideration, that supply chains communicate inefficiently, that the evaluation of registration dossiers and substances is too complex while the authorisation procedure is too rigid. Finally, the Commission believes the restriction process currently in place is too slow to adequately protect consumers and professional users against risks from the most hazardous substances while enforcement is not handled equally in all EU Member States. The Commission has, therefore, said there should be a greater focus on ‘broad restrictions’ and that more data is needed (including at lower tonnage thresholds), all of which would appear likely to increase costs for industry.
The measures currently identified to be addressed by the revisions are the following:
- Revising the registration requirements;
- Introducing a Mixtures Assessment Factor (“MAF”) to address the risks of exposure to multiple substances (combination effects);
- Simplifying supply chain communication by improving safety data sheets;
- Revising the provisions for dossier and substance evaluation to ensure registration dossiers are in compliance;
- Reforming the authorisation process, such as by removing the authorisation title from REACH or integrating the REACH authorisation and restriction systems into one;
- Reforming the restriction process; and
- Revising the provisions for control and enforcement by, for instance, establishing minimum requirements for national controls and enforcement.
Again, the Commission warns that some changes to REACH will increase costs for companies throughout the supply chains as a result of increased information requirements and/or the introduction of new risk management measures. The actual costs will vary depending on an operators’ position in the supply chain and its size. At the same time, the Commission believes that additional costs will to some extent be off-set by the greater legal certainty/transparency the changes will introduce.
A streamlining of the authorisation process would be a welcome development, with the Commission acknowledging the system places EU-based companies at a competitive disadvantage compared to non-EU competitors.
The focus on combination effects of chemicals in particular could lead to significant changes. The Commission notes that registrants are only responsible for their own substances and do not take into account the fact that humans and the environment are exposed to a large number of different substances from different sources. When further details are released on the Mixtures Assessment Factor these should be considered carefully to assess the impact on currently available products.
The inception impact assessment makes it clear that the intention is to push industry towards innovation and substitution, both of which will sound alarm bells in terms of cost and time for companies who have worked to comply with the current REACH requirements.
The roadmaps are open for feedback until 1 June 2021. The Commission will then take the feedback into account and explain in a synopsis report which suggestions, if any, will not be taken on board and why. At the same time, the feedback will be published on the Commission’s website and will form the basis for the actual legislative proposals. Afterwards, another formal public consultation will be held for 12 weeks (date to be announced but likely to be in the second half of 2021). The current aim is for the CLP revision to be published in draft in Q2 of 2022, with the REACH revision following suit in Q4 of 2022.