EU Regulation on the Evaluation and Control of Risks of Existing Substances (EEC 793/93)
This applies directly in the UK. It requires that manufacturers and importers of any listed substance in the EU submit specified data on that substance including its eco-toxicity and information on its pathways in the environment. The format of the data is strictly prescribed.
Existing substances are those listed in the European Inventory of Existing Chemical Substances (EINECS) -
published in the Official Journal of the EC (Ref: OJ C146 15 June 1990), available from the Stationery Office.
Introduces bans on the use and supply of ozone depleting substances, in addition to previous bans on production and importation. The prohibition on use refers to using controlled substances in the production or maintenance, and in particular refilling, of products or equipment or in other processes – except if the controlled substances are used as a chemical feedstock or processing agent. This means that controlled substances can be used in ‘closed systems’ (eg refrigeration) but that none can be added to the systems for maintenance or top up. Controlled substances include CFCs, other fully halogenated chloroflurocarbons, halons, carbon tetrachloride, 1,1,1trichloroethane and hydrobromofluorocarbons. There are different phase-out dates listed for various substances and uses.
Environmental Protection (Controls on Ozone Depleting Substances) Regulations 2002 (SI 2002/528)
These Regulations implement Council Regulation (EC) No. 2037/2000 on substances that deplete the ozone layer. They are therefore strengthening existing controls on these controlled substances, by prohibiting the placing on the market, use, trade in and emission of certain substances that deplete the ozone layer. In this case, ‘use’ refers to a top-up of these substances during maintenance, so where use within everyday operation is still acceptable, companies will not be able to use ozone depleting substances when equipment is repaired or maintained.
Controlled substances include chlorofluorocarbons (CFCs), other fully halogenated chlorofluorocarbons, halons, carbon tetrachloride, 1,1,1-trichloroethane and hydrobromofluorocarbons. There are different phase-out dates for the various substances and their various uses.
REACH - Registration, Evaluation and Authorisation of Chemicals
The European REACH regulation (1907/2006/EC) entered into force on 1 June 2007. It places greater responsibility on industry to manage the risk of chemicals and provide appropriate safety information to professional users and consumers.
REACH consists of three main stages:
- Registration – Importers and manufacturers of substances (and some downstream users) in quantities over 1 tonne per year must register their substance with a new European Chemicals Agency based in Helsinki
- Evaluation – Member State competent authorities will review registration packages and request further information or testing to determine the impact of the substance on human health and the environment
- Authorisation or Restriction – Decisions regarding what substances require an authorisation or restriction will be carried out at EU level by the Commission for substances that pose the most concern, such as carcinogens and mutagens
REACH will replace 40 existing legal acts and create a single system for all chemical substances.
Currently about 30,000 substances are in the EU market at volumes above 1 tonne.
REGISTRATION
Registration is proposed to take place in three stages based on production/usage tonnage:
i. November 2010: Registration deadline for:
- substances in quantities of 1000 tonnes per year and above.
- carcinogens, mutagens and substances toxic to reproduction (CMR category 1 and 2) above one tonne per year.
- substances classified as very toxic to aquatic organisms (R50/53) above 100 tonnes per year.
ii. June 2013: Registration deadline for substances in quantities of 100 tonnes per year and more.
iii. June 2018: Registration deadline for substances in quantities of 1 tonne per year and more.
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.
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 which in the UK is HSE.
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
AUTHORISATION AND RESTRICTION
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).
Responsibilities for industry
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.