Legislation in this area is driven by the EU, and there is a whole raft of Directives and Regulation covering the supply of chemicals.

 
What is the difference between a directive and a regulation?

Directives (e.g. the Dangerous Substances Directive 67/548/EEC) are implemented through national legislation in each EU Member State, while Regulations (e.g. the REACH Regulation EC 1907/2006) are directly acting and do not need to be transposed into national legislation, although there may be legislation to deal with any transition periods and to enable enforcement enacted in each Member State.

  

Registration

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was introduced with the aim of:

  • Improving the protection of human health and the environment from the risks that can be posed by chemicals
  • Enhancing the competitiveness of the EU chemicals industry, a key sector for the economy of the EU
  • Promoting alternative methods for the assessment of hazards of substances
  • Ensuring the free circulation of substances on the internal market of the European Union

REACH places a greater responsibility for ensuring the safety of chemicals and products containing them on manufacturers and importers. REACH also places requirements on distributors and downstream users to facilitate the communication of hazard information up and down the supply chain.

Before a manufacturer or importer can place a new chemical substance on the market, it must be Registered. Registration is required for all substances placed on the market in quantities of 1 tonne or more per manufacturer per year.  For so called ‘phase-in’ substances, there are transitional arrangements which extend the deadline for Registration until 1 Dec 2010, 1 Jun 2013, or 1 Jun 2018, depending on the quantity manufactured/imported and the hazards of the substance.

Registration involves completing a dossier of information about the hazards of the chemical substance, the risks arising from its intended use, and the classification and labelling to be applied to the chemical.

Once Registered, the chemical substance may be selected for further Evaluation, and, if considered to be of sufficient concern, then it may be subject to Authorisation.

The Registration requirements of REACH apply to chemical substances, i.e. single substances (including any impurities and/or necessary stabilisers). For formulated mixtures of substances, Registration is required for each component substance added to the mixture, if the quantity of that substance Manufactured/Imported is greater than 1 tonne/year.

Only legal entities registered within the EU can Register their substances under REACH. Non-EU manufacturers cannot register themselves, however they can appoint an EU-based Only Representative to register on their behalf. 

 


Classification, Labelling and Packaging

Europe is currently in transition between two systems of classification, labelling and packaging:

These two systems are fundamentally similar in that they require suppliers of chemicals to assess the hazardous properties of their chemical substances and preparations (mixtures), and, if they meet the various criteria for any of the hazard categories to classify them accordingly, assign the appropriate hazard information, and to communicate this information via labels and safety data sheets (SDS).


The DSD and DPD are implemented in the UK through the CHIP Regulations.

CLP provides transitional arrangements to allow time for suppliers to re-classify and re-label their products.

 

 

 

Forthcoming developments:

  • A 1st ATP is expected to be published shortly, which will implement the 30th and 31st ATPs to the DSD in Table 3.2 of CLP
  • Also expected is an amendment to cover the changes required to Safety Data Sheets as a result of the introduction of CLP