REACH is a new European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorization and Restriction of Chemical substances. The new law entered into force on 1 June 2007.
Virtually, the raw materials we offered didn’t appear in the list, and also have been pre-registered in ECHA by Shin Dorn. It’s reasonable to believe that to cooperate with Shin Dorn effectively and reliability.
* the SVHC List
* Certificate of REACH Pre-registration
Objectives
- Improve the protection of human health and the environment from the risks that can be posed by chemicals.
- Enhance the competitiveness of the EU chemicals industry, a key sector for the economy of the EU.
- Promote alternative methods for the assessment of hazards of substances.
- Ensure the free circulation of substances on the internal market of the European Union.
The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. At the same time, innovative capability and competitiveness of the EU chemicals industry should be enhanced. The benefits of the REACH system will come gradually, as more and more substances are phased into REACH.
The REACH Regulation gives greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. Manufacturers and importers will be required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database run by the European Chemicals Agency (ECHA) in Helsinki. The Agency will act as the central point in the REACH system: it will manage the databases necessary to operate the system, co-ordinate the in-depth evaluation of suspicious chemicals and run a public database in which consumers and professionals can find hazard information.
One of the main reasons for developing and adopting the REACH Regulation was that a large number of substances have been manufactured and placed on the market in Europe for many years, sometimes in very high amounts, and yet there is insufficient information on the hazards that they pose to human health and the environment. There is a need to fill these information gaps to ensure that industry is able to assess hazards and risks of the substances, and to identify and implement the risk management measures to protect humans and the environment.
What is REACH?
REACH is the Regulation for Registration, Evaluation, Authorization and Restriction of Chemicals. It entered into force on 1st June 2007 to streamline and improve the former legislative framework on chemicals of the European Union (EU). REACH places greater responsibility on industry to manage the risks that chemicals may pose to the health and the environment.
In principle REACH applies to all chemicals: not only chemicals used in industrial processes but also in our day-to-day life, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances.
Registration
Registration requires producers and importers to submit information on chemical substances produced in or imported to the EU market in quantities above 1 t/year.
What to register?
It is important to note that only substances – no preparations or finished products are subject to registration.
Substances on their own or in preparations
Substances should be registered on their own or in preparations, if the substances are produced or imported in volume >1t/year.
Polymers are exempted from registration, however, monomers in polymers should be registered, if the concentration is >2% weight by weight and the total annual volume is > 1t/year.
Substances in finished products
Substances in finished products should be registered, if:
- they are intended to be released under normal or reasonably foreseeable conditions of use.
- they are contained in volume > 1 t/y.
To assess the annual volume, you should check the volume of the substance contained in all products produced or imported per legal entity.
Substances in finished products should be first notified to the Agency, if:
- the substances are meeting the criteria of Carcinogenic, Mutagenic and toxic to Reproduction, (CMR), Persistent, bio-accumulative and toxic (PBT), very Persistent, very bio-accumulative (vPvB);
- the substance is contained in a product in volume > 1t/year;
- the concentration is above 0.1 % weight by weight;
- exposure cannot be excluded.
The Agency may decide that registration is needed, if there are “grounds for suspecting” that release of the substance presents a risk to health or environment.
Evaluation
Evaluation allows the regulatory authorities to assess whether information provided by industry is complete. They can decide whether more testing is needed, if a substance may cause a risk to health or the environment. Based on the information provided by industry, the authorities may decide that the use of a given substance should be restricted.
The Commission will prepare a 3 year rolling action plan setting priority substances for evaluation. The criteria for inclusion will be hazard, exposure and tonnage.
Authorisation
Authorisation is a process which starts with the identification of Substances of Very High Concern (SVHC), which is done by the EU Member States together with ECHA (the European Chemicals Agency) on the Candidate List. The identification is followed by priority setting of substances. ECHA makes a recommendation to the European Commission on which substances should be prioritised to be restricted. Based on this recommendation the Commission decides, if a substance should be banned by including it in Annex XIV. From that moment on producers, importers and downstream users will have to ask for authorisation for a specific use of the substance.
Around 2000 substances are eligible for inclusion on the Candidate List, however these substances will be gradually included. The first list of substances with candidates for a potential ban was published in October 2008 listing 15 substances. It will be updated twice a year, in December and June. The list will not have a prohibitive effect and the use of the listed substances can continue. However, as soon as a substance is published on the candidate list there are immediate obligations .
Restrictions
From 1 June 2009, the REACH restriction process entered into force. Member States or ECHA (on behalf of the Commission) can start a process to restrict the manufacturing, placing on the market or use of a chemical substance. Any substance on its own, in a preparation or in an article may be subject to Community-wide restrictions, if its use poses unacceptable risks to health or the environment. The Commission is currently working on the restriction of several substances. Restrictions can be decided either for the use of a substance in certain products, the use by consumers or for all uses (complete ban of a substance).
REACH Pre-Registration
The main period during which pre-registration of substances previously manufactured or imported into the EU (thus securing a phase in period before full registration will be required) was possible has now closed. In some cases late pre-registration can still be made.
Why REACH?
REACH replaces about 40 pieces of legislation with a streamlined and improved Regulation. Other legislation regulating chemicals (e.g. on cosmetics, detergents) or related legislation (e.g. on health and safety of workers handling chemicals, product safety, construction products) not replaced by REACH will continue to apply. REACH has been designed not to overlap or conflict with the other chemical legislation.
How will REACH work?
REACH makes industry bear most responsibilities to manage the risks posed by chemicals and provide appropriate safety information to their users.
In parallel, it foresees that the European Union can take additional measures on highly dangerous substances, where there is a need for complementing action at EU level.
REACH also creates the European Chemicals Agency (ECHA) with a central coordination and implementation role in the overall process.
All manufacturers and importers of chemicals must identify and manage risks linked to the substances they manufacture and market. For substances produced or imported in quantities of 1 tonne or more per year per company, manufacturers and importers need to demonstrate that they have appropriately done so by means of a registration dossier, which shall be submitted to the Agency.
Once the registration dossier has been received, the Agency may check that it is compliant with the Regulation and shall evaluate testing proposals to ensure that the assessment of the chemical substances will not result in unnecessary testing, especially on animals.
Where appropriate, authorities may also select substances for a broader substance evaluation to further investigate substances of concern.
REACH also foresees an authorisation system aiming to ensure that substances of very high concern are adequately controlled, and progressively substituted by safer substances or technologies or only used, where there is an overall benefit for society of using the substance. These substances will be prioritised and over time included in Annex XIV. Once they are included, industry will have to submit applications to the Agency on authorisation for continued use of these substances. In addition, EU authorities may impose restrictions on the manufacture, use or placing on the market of substances causing an unacceptable risk to human health or the environment.
Manufacturers and importers must provide their downstream users with the risk information they need to use the substance safely. This will be done via the classification and labelling system and Safety Data Sheets (SDS), where needed.
Substances can be exempted from all or a part of the obligations under REACH. These exemptions are not described in detail in this part of the web-site (About REACH). More information on exemptions can be found when using the navigator. Companies are strongly advised to use the navigator to find out if their substance is covered by an exemption under REACH.