REACH - Registration, Evaluation and Authorisation of Chemicals

Businesses can register voluntarily before the deadlines. Registration dossiers can be submitted to the European Chemical Agency (ECHA) from 1 June 2008

New substances must be registered before being placed on the market. Registration will start on 1 June 2008.

Pre-registration

Manufacturers and importers are encouraged to pre-register their substances in order to take advantage of the transitional periods for registration. Manufacturers and importers who fail to pre-register will be required to register, in full, 12 months after REACH enters into force. Any manufacturer or importer who does not pre-register cannot expect to rely on support from SIEFs (Substance Information Exchange Forums), which are formed by pre-registrants after the pre-registration phase ends, and consotias.

OSOR

One Substance One registration (OSOR) allows groups of producers, importers and users of substances to join together and register a substance between them in a consorta. This minimises the need for duplicate testing effort and facilitate the sharing of animal testing data which is mandatory under REACH. It also reduces the individual cost of registering substances.

Preparations and Articles

REACH also requires the registration of substances (greater than 1 tonne per year) within preparations (mixtures of substances) and some (but not all) substances in articles (i.e. where there is an intentional release of a substance from an article).

An article “means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition”.

Exemptions

There are some specific exemptions to the regulation for registration of substances. These are listed in Annex’s IV and V of the proposal and include natural gas, oil, coal and carbon.

3. Evaluation

A new European Chemicals Agency (ECHA) based in Helsinki is being developed to evaluate chemical registration dossiers at community level. To ensure no unnecessary animal testing is carried out ECHA scrutinises all testing proposals within a registration dossier. However, only 5% of all registration dossiers will be subject to a full ECHA compliance check.

REACH requires that Member States establish a competent authority to carry out substance evaluation. DEFRA have nominated HSE to be the UK competent authority for REACH. HSE will play a key role in enforcing REACH, both as the UK Competent Authority and more generally as the UK occupational health and safety regulator. HSE are working closely with other regulators to support DEFRA in setting up the framework for enforcing REACH in the UK.

Member States and the European Commission will agree on an annual list of substances to be assessed in-depth. This may lead to new control measures (i.e. authorisation, substitution or restriction) or to no further action

Companies using certain substances of very high concern (SVHCs) must apply for an authorisation to continue using the substance. A company may gain authorisation where:

• The substance is adequately controlled in line with safe exposure thresholds
• If the socio-economic benefits outweigh the risks

If a company identifies suitable alternatives, it will have to submit a substitution plan including a timetable for proposed actions. Where no ‘viable alternative’ exists, a research and development plan to derive a suitable alternative must be submitted with the authorisation application. The regulation also enables the restriction of certain substances placed on the market where there is an unacceptable risk to human health and the environment.

NB. SVHCs include: carcinogenic, mutagenic and reprotoxic substances (CMRs); persistent, bio-accumulative and toxic (PBT); and very persistent and very bio-accumulative (vPvB).

REACH places greater responsibility on industry to manage the risk of chemicals and provide appropriate safety information to professional users and, where necessary, to consumers.

Manufacturers/Importers

Manufactures and Importers must use safety data sheets (SDS) to communicate the safe use of a substance through the supply chain. For substances manufactured, imported, or used in quantities over 10 tonnes per year an additional more detailed chemical safety report (CSR) is required as well. An organisation registering their substance must evaluate its impacts for a range of use or ‘exposure scenarios’. Information on safe use of a substance within these categories must then be placed in an Annex to the SDS.

Downstream Users

Primarily, it will be the supplier (importer or manufacturer) of a substance that will be responsible for registration. However, all downstream users of a substance must check that their supplier has registered their intended use of that substance - This allows the manufacturer or importer to include these uses in the risk assessment and management information in the SDS. Downstream users must ensure that they apply the risk management measures identified by the supplier and communicated to them via Safety Data Sheets (SDS) and pass this information down the supply chain.

If a particular substance use has not been registered, the downstream user can request that their supplier register the substance for their defined use, if the supplier refuses or the downstream user wishes to keep their use confidential, they may register their substance directly with the Agency.

It is important to note that not all manufacturers and importers may decide to register substances. Withdrawing substances from the market may be due to high registration costs or to the fact that a certain substance may be subject to authorisation or restriction. It is important, therefore, that downstream users engage with their manufactures/ importers to understand their intentions on complying with REACH.