Chemical Regulation in the EU: REACH

REACH

Registration, Evaluation, Authorisation and Restriction of Chemicals, (REACH), is a set of European regulations which aim to improve the protection of human health and the environment while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry. REACH came into force in 2007 but continues to be implemented by stages. Although REACH replaces about 40 other pieces of chemicals legislation in the EU, it does not replace legislation on specific types and uses such as cosmetics, pesticides, medicines and biocides, which all have their own regulations. REACH is aimed primarily at chemicals used in industry either as main feedstocks or as intermediates in the manufacturing process.

The guiding principles of REACH are:

  • Sustainable Development
  • Protection of human health and the environment
  • Innovation & Competitiveness of EU Chemical industry
  • Prevention of fragmentation of the Internal Market
  • Increased Transparency and consumer awareness
  • Integration with international efforts
  • Promotion of non-animal testing

REACH will be a single, coherent system for new and existing chemicals with the three new elements of Registration, Evaluation andAuthorisation of Chemicals. It will also be a tiered approach to chemicals with a focus on chemicals in high volumes or of great concern.

Registration will require the following data:

  • Data/information on identity and properties of substances (including data on toxicological and ecotoxicological properties)
  • Intended uses, estimated human and environmental exposure
  • Production quantity envisaged
  • Proposal for the classification and labelling of the substance
  • Safety Data Sheet
  • Preliminary risk assessment covering the intended uses
  • Proposed risk management measures

Responsibilities

As originally conceived the responsibilities for REACH would fall thus:

  • Industry responsible for generating the knowledge about chemicals including preliminary risk assessments
  • Application of precaution, in case industry is not performing
  • Downstream users obliged to assess the safety of their products
  • Member State Authorities collectively responsible for evaluating data under Registration and Evaluation phases

REACH created a new agency, The European Chemicals Agency, (ECHA), based in Helsinki, (http://echa.europa.eu/) to manage the registration, evaluation, authorisation and restriction processes for chemical substances to ensure consistency across the European Union.

The EU and the OECD have supported the development of a number of software tools to help companies register their chemicals. In addition to templates for actual registration, the tools include a number of programmes for predicting some of the toxicological properties that REACH requires, (such as mutagenicity, carcinogenicity and skin sensitivity). It is expected that much of this information can be generated from existing databases, from “read across”, (by analogy to closely related compounds), or by QSAR, (Quantitative Structure Activity Relationships; see elsewhere on this website for details). These tools TOXTREE, TOXMATCH, and the OECD QSAR Application Toolbox, are extremely useful, and the European Industry Council, (CEFIC) has also produced a database tool called AMBIT. These tools, are freely available though they do require some training and a certain level of knowledge of computational chemistry.

Please contact us for more information