REACH Article 138 1-10 tonnes reviews REF: 909

Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) came into force on 1 June 2007.  REACH aims to provide a high level of protection of human health and the environment, while at the same time enhancing the competitiveness and innovative capability of the EU industry.

Article 138 of REACH requires the Commission to undertake reviews of the requirements for substances manufactured or imported in quantities of 1-10 tonnes per year per manufacturer/importer and, on the basis of these reviews, present any legislative proposals to modify the requirements as required.

The reviews under Article 138 specifically identify requirements on:

• the physico chemical, toxicological and ecotoxicological information that must be submitted in registration dossiers; and
• the obligation to perform a chemical safety assessment (CSA) and to document it in a chemical safety report (CSR) and state whether it should be extended to 1-10 substances identified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A or 1B.

Following on from the initial Phase 1 study (2012) that RPA had completed for the Commission on these issues, RPA was again commissioned (in December 2013) for a second phase of study that would:

• identify, refine and analyse options for an extension of the current information requirements and provide sufficient information on the costs, benefits and impact on innovation and competitiveness of each of the options;
• provide a clear description of the envisaged main benefits and drawbacks of the extension of CSA/CSR obligations to 1-10t CMR 1A/1B substances including estimation of costs for manufacturers, importers and downstream users and distribution of the costs along the supply chain; and
• provide the Commission with a solid basis to report on the issues and envisage any (legislative) proposals.

On the basis of the outputs from the Phase 2 study and internal discussions, the Commission selected five options for extending information requirements for further evaluation and assessment both in isolation and in combination with options for extending the CSA/CSR obligation.

RPA was commissioned to conduct a third phase of study to generate further information on the selected policy options.  This required refining and adjusting the methods developed in Phase 2 to take into consideration the new combination of options, changes in context and timing of any changes since Phase 2 was undertaken and the development of new approaches to the assessment of the human health and environmental benefits of identifying hazardous substances.

An Excel® based Monte Carlo model and simulation was developed to analyse and explore the options and the baseline (current requirements) in terms of the following key performance measures:

1. the number of substances with hazardous properties detected;
2. the usefulness of the information generated on these substances in the context of the regulation of risks and risk management;
3. the likely number of disease cases/environmental damage avoided and the economic value of this;
4. the cost of registering/updating the 1-10t substances (including the generation of information);
5. the likely impact of registration costs at a company level considering that companies will be registering several substances (a portfolio) sometimes as part of a joint (consortium) registration and sometimes as an individual registration; and
6. considering the above, to the extent possible, the likely impacts on SMEs, competition and innovation.

The results of the study were presented to CARACAL (the expert group of Competent Authorities for REACH and CLP) in March 2017 and may be used as part of the preparation of a Commission Impact Assessment (IA) and Public Consultation on the issue in the future.