REACH is the European Union rules and the Registration, Evaluation, authorization and Restriction of Chemicals (REGULATION concerning the Registration, Evaluation, Authorization and Restriction of Chemicals), was established in the European Union, and on June 1, 2007 implemented Chemicals regulatory system
This is regulatory proposals involved in a chemical production, trade, use which is designed to protect human health and environmental safety, to maintain and enhance the competitiveness of the European chemical industry, and develop the innovative ability of non-toxic harmless compounds, prevent market division, increases the transparency of chemicals used, to promote the animal experiments, the pursuit of sustainable development of the society, etc .REACH directive requires whoever imports and production within the territory of the European, chemicals must be through the registration, evaluation, authorization, and restriction, etc. A set of integrated programs, in order to better and more easily identify the chemical composition to achieve the purpose of ensuring the security of the environment and the human body. The directive mainly includes several major contents including registration, evaluation, authorization and restriction. Any commodity must have a list of chemical components and explain how manufacturers use these chemicals and toxicity assessment reports. All information will be entered into a database that is under construction, managed by the European chemicals agency, a new EU body in Helsinki, Finland. The agency will assess each archive and may take more stringent measures if chemicals are found to have an impact on human health or the environment. Depending on the assessment of several factors, chemicals may be banned or require approval before they can be used.
According to the introduction, unlike RoHS directive, REACH involves a wide range of scope, in fact it affects products and manufacturing processes from mining to textile clothing, light industry, electromechanical and other industries .REACH requires manufacturers to register every chemical component of the product, which is about 30, 000 -- and to measure its potential for public health. REACH established the idea that society should not introduce new materials, products or technologies if their potential harm was not known. Mechanical and electrical products have been one of the most important foreign trade in Ningbo. As a downstream user of chemical industry, there is no mechanical and electrical machinery for European trade
Companies can be exempt from REACH. The REACH regulation provides that producers and importers of chemicals and other physical products entering the EU market bear the following obligations:
(1) to organize and submit detailed reports (i.e. "registration") including the test data of each chemical substance contained in the product. In the REACH code, the registration scope of chemical substances mainly includes:
1. The quantity is greater than or equal to 1 ton/year/person's independent existence of substances or products;
2. The unregistered content of the upstream supplier (weight ratio) is greater than 2% and the total amount is greater than 1 ton/year/person's monomer or other substance in the polymer.
3. The total amount of 1 tons/year/person and normal or reasonable foreseeable use of substances in the use of substances (substances in articles);
4. The total amount of >1 tons/year/person, the chemical bureau has reason to suspect that the release of substances from objects and the release of substances harmful to the human body or the environment may require registration
In the REACH regulation, the exempted registered substances are:
1.1 tons/year/person material
2. Radioactive material
(1) temporary storage for re-export, or bonded area or bonded warehouse; Or (2) transit
4. Non-separation intermediate
Transport of dangerous substances
7. The member states are exempted from the defense
Medicine or veterinary medicine
9. Additives, food flavorings and animal nutrition agents in food or feed
10. The substance in annex IV (known risk is low)
11. Substances in annex V
12. Re-import substances in the registered substances themselves or products
13. Recovery process when a registered substance, product or substance is processed again.
14. Polymer injection (itself) (but not registered in the upstream suppliers/weight ratio is 2% or higher and a total of 1 ton/year or more in a single unit (monomericunits) or compound (chemically bound substances) form exists in monomer in the polymer or other substances except)
15. Chemical (PPORD) only for products or r&d (5 +5/10 years)
16. Only active ingredients and auxiliary materials (co - formulants) for plant protection products (as registered)
17. Active ingredients used only in biocide (as registered)
18. Substances declared by new chemicals (as registered) have been made according to the 79/831/EEC directive.
(2) evaluate the safety factor of each chemical in the product (" chemical safety assessment ").
The contents of the assessment are:
1. Archives evaluation is the completeness and consistency of the verification enterprise's submission of registration documents.
2. The material assessment is to check whether the material needs further information from the enterprise.
3. Evaluation mainly includes Dossier Evaluation and substance Evaluation. Dossier Evaluation includes:
-The European chemical authority shall, within 3 weeks after registration, provide the registrant's registration information and integrity inspection report to the competent authority of Member State. However, the registration documents received within 2 months from the date of registration are subject to three months of examination;
-Non- phase registered material as well as the deadline of the registration materials in stages, before the audit failed, production, sales, use and import ban on EU countries (competent authority of the member states to review technical documents: evaluate registration technical documentation is in compliance with the provisions of the laws and regulations, and check the animal test plan, in order to avoid unnecessary animal test);
-EU member states review the draft test submitted and draft resolutions. The resolution is as follows:
(1) agree to carry out the experiment and submit the experimental result summary and the research method for constructive analysis within the deadline (as specified in annex I).
(2) the resolution same as a, but proceed under the revised test conditions.
(3) the resolution is in accordance with a, b or d, but when the submitted test objectives are inconsistent with the requirements of the attachment, one or more tests are required.
(4) rejection of the proposed experiment.
(5) if several registrants submit the same test proposal as a, b or c, the authority shall coordinate its agreement within 90 days to find an experiment to represent all of them.
(6) the agreed experiment shall have a public notice period of 45 days.
Substance Evaluation includes:
- the authority provides the criteria for assessment of priority substances for member states;
-- on December 1, 2011, the draft plan will be provided for evaluation of the rolling plan, followed by February 28 each year;
-. The member states of the selected materials have been selected for a continuous three-year assessment of the rolling plan and assessed;
- the authority will ultimately evaluate the listing online;
EU member states shall draft relevant resolutions (180 days of new material) within the prescribed time limit for further information..
(3)Special authorization for use according to the different nature of chemicals.
The registration of REACH directive stipulates that only eu enterprises can register .If Chinese companies are to register in the eu, they have to choose the agency of the European Union, which actually includes agency fees, inspection fees and registration fees. It is widely estimated that the basic testing cost of each chemical is about 85,000 euros, and the detection cost of each new substance is about 570, 000 euros. The increase of the cost of chemical industry is bound to cause a chain reaction of downstream industries. For the electromechanical enterprises that already have not much profit space, the export situation is less optimistic.
The inspection and quarantine organ reminds the relevant production enterprises to attach great importance to the impact of the implementation of REACH regulations. The production operator must establish the concept of green production and green marketing. Respond as soon as possible, follow the legislative progress further, import products, research and development, using non-toxic, low toxicity, apply for registration to the export of chemical products, strengthen inspection, timely reflect the technical barriers encountered problems, to study and improve the production, to ensure that risk aversion. Only by continuous development with independent intellectual property rights of dominant industry and master the WTO rules of the game, can better avoid technical barriers to trade, export products is minimized blocked caused economic losses. Want to win the market to improve product technology content, raise awareness of intellectual property rights and market prospects of developing new products, more efforts to developing alternative environmental protection material, improve the quality of export products, constantly adjust their production technology and product formulations.
It should be noted that many electromechanical companies have little knowledge of the new EU rules. First, the inspection and quarantine department reminded the electromechanical enterprises to respond positively. The negative wait and see will delay the wrong time, the enterprise can get trough relevant training and the seminar to know the latest progress of REACH system. At the same time, the inspection and quarantine bureau will continue to release relevant information to the enterprise. Secondly is active to know. Enterprises need to change the habits of the past simply rely on the government to guide thinking, through the industry association, the European Union, clients, agents, foreign institutions such as a variety of sources to understand information, extended source, a comprehensive grasp the relevant dynamic. Thirdly Make timely attack. The electromechanical enterprises should pay close attention to the situation of the upstream chemical enterprises to deal with the REACH system, so as to make the selection work of the raw material suppliers early so as not to affect the production.
Protecting human health and environmental safety is the common goal of all countries to achieve sustainable development. The REACH regulation has an unusual significance for our domestic environmental protection and trade management regulations .For enterprises, now that China has joined the WTO, the economy has been globalized, and the enterprises can not focus on the immediate goals, but not the development of the international market. While the REACH regulation is suspected of technical barriers, some polluting enterprises and products will be eliminated as environmental requirements increase. Related, therefore, the enterprise must speed up the adjustment of product structure, improve product quality, improve the requirements of environmental protection, strengthen the ability of product updates, at the same time more should focus on the international market dynamics, to strengthen trade skills, and constantly improve the international competitiveness.