EU reach published in December 2006
EU REACH is covered in the Regulation (EC) No 1907/2006, which was published in December 2006 and entered into force in June 2007. REACH stands for Registration, Evaluation, Authorization and Restriction of Chemicals. EU REACH streamlines and improves the former legislative framework on chemicals in the EU.
EU REACH aims to ensure:
- A high level of protection for human health and the environment
- The promotion of alternative methods for assessment of hazards of substances
- Free circulation of substances on the internal EU market
- Enhancing competitiveness and innovation
REACH is based on the idea that industry itself is best placed to ensure that the chemicals it manufactures and puts on the market in the EU do not adversely affect human health or the environment.
REACH divides the substances into 2 categories:
- Non-phase-in substances (those not produced or marketed prior to the entry into force of REACH)
- Phase-in substances (those substances listed in EINECS, or those that have been manufactured in the EU, but not placed on the EU market, in the last 15 years or the so called “no longer polymers” of Directive 67/548)
REACH is covering all substances, whether manufactured, imported, used as intermediates or placed on the market, either on their own, in preparations(such as cosmetics) or in articles, unless they are radioactive, subject to customs supervision, or are non-isolated intermediates. Waste is specifically exempted.
Manufacturers or importers of substances in quantities exceeding 1 tonne of the substance per year must comply with REACH, and must submit a registration to the European Chemicals Agency.
Certain substances, however, don’t require registration:
- Substances that are adequately regulated under other legislations (such as medicinal products or low risk substances)
- Substances occurring in nature (like minerals, ores, ore concentrates) if they are not chemically modified
- Polymers (in certain circumstances monomers in polymers have to be registered)
- The exemptions are listed in Annexes IV and V of the REACH regulation
For the substances on their own or in preparations, manufacturers or importers have to submit the following registration documents to the Agency:
- A technical dossier for substances in quantities of 1 tonne or more
- A chemical safety report for substances in quantities of 10 tonnes or more
A registration means that the manufacturer or importer has provided a registration dossier to the European Chemicals Agency and not receive any indication that the dossier is incomplete. This, however, does not by itself mean approval.
To find out the properties of the substances, information requirements are set out in the testing annexes that vary according to the tonnage in which the substance is manufactured or imported, and to the needs of the chemical safety assessment. The tonnage ‘trigger’ has been chosen as it gives an indication of the potential for exposure. Tonnage for phase-in-substances is calculated as a three year average as long as they have been manufactured or imported for 3 consecutive years.
The information that has to be submitted:
- Substances in quantities of 1 to 10 tonnes:
- Substances meeting at least one of the two criteria set out in Annex III: a defined set of information from Annex VII along with any other available information has to be submitted
- Other substances: physicochemical information and any available and relevant (eco)toxicological information
- Substances in quantities of 10 to 100 tonnes:
- Information from the application of the relevant testing Annexes VII and VIII needs to be submitted as well as all other available and relevant information
- Substances in quantities of 100 tonnes or more:
- Information from the application of Annexes VII and VIII needs to be submitted as well as all other available and relevant information
- If the manufacturer or the importer does not possess the required information from Annex IX, and for the substances at or above 1000 tonnes, Annex X, proposals for testing for the purpose of registration need to be submitted
The chemical safety report (CSR) for substances manufactured or imported in quantities starting at 10 tonnes, documents the hazards and classification of a substance and the assessment as to whether the substance is PBT or vPvB. The CSR also describes exposure scenarios for specific uses of substances that are classified as dangerous or are PBT or vPvB substances.
For phase-in substances, more registration deadlines are established for their different tonnage ranges. Additionally, some high concern substances need to be registered early. See the deadlines below:
For the registration of substances in articles (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), a special regime applies:
- All substances which are intended to be released from articles should be registered according to the normal rules, including tonnage deadlines and information requirements, when present in the articles in quantities of 1 tonne or above
- All substances of very high concern present in articles above a concentration limit of 0.1 % weight by weight and present above 1 tonne per year must be notified to the European Chemicals Agency except where exposure to humans and environment can be excluded during normal conditions of use including disposal. In such case safety instructions should be provided. Information will also be made available to consumers on request.
The communication requirements of REACH ensure that not only manufacturers and importers but also their customers, i.e. downstream users and distributors, have theinformation they need to use chemicals safely. Information relating to health, safety and environmental properties, risks and risk management measures is required to be passed both down and up the supply chain.
AUTHORIZATION AND RESTRICTIONS
Substances of very high concern require an authorization for their use and their placing on the market.
The following substances require authorization:
- CMR category 1 and 2
- PRT, vPvBs
- Identified from scientific evidence as causing probable serious effects to humans or the environment equivalent to those above on a case-by-case basis, such as endocrine disrupters.
REACH Regulation also deals with the restrictions of substances which pose an unacceptable risk to health or the environment. All activities with a substance which are not restricted are allowed under REACH unless the substance is included in the authorization system.
CLASSIFICATION AND LABELLING
EU REACH is promoting an agreement on the hazard classification (and consequently labelling) of all dangerous substances either manufactured in the EU, or imported into the EU.