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REACH certification
Product range:
REACH is the abbreviation of the EU regulation "REGULATION concerning the Registration, Evaluation, Authorization and Restriction of Chemicals", which is a chemical regulatory system established by the European Union and implemented on June 2007, 6.
This is a proposal for regulations related to the safety of the production, trade and use of chemicals, which aims to protect human health and environmental safety, maintain and improve the competitiveness of the EU chemical industry, as well as the innovative ability to develop non-toxic and harmless compounds, prevent market fragmentation, increase transparency in the use of chemicals, promote non-animal experimentation, and pursue sustainable social development. The REACH Directive requires that chemicals imported and produced in Europe must go through a comprehensive set of procedures such as registration, evaluation, authorization and restriction to better and more simply identify the composition of the chemical to ensure environmental and human safety. The directive mainly includes registration, evaluation, authorization, restrictions and other major contents. Any product must have a registration file listing chemical composition, a description of how the manufacturer uses these chemical compositions, and a toxicity assessment report. All information will be entered into a database under construction managed by the European Chemicals Agency, a new EU body based in Helsinki, Finland——— The agency will evaluate each dossier and may take more stringent measures if it finds that chemicals have an impact on human health or the environment. Depending on the assessment of several factors, chemicals may be banned or may require approval before they can be used.
According to reports, unlike the RoHS directive, REACH covers a much wider scope, in fact, it will affect almost all industries from mining to textile and garment, light industry, electromechanical and other products and manufacturing processes. REACH requires manufacturers to register about 3,<> chemical ingredients in their products – and to measure their potential harm to public health. REACH establishes the idea that society should not introduce new materials, products or technologies if their potential hazards are uncertain. Mechanical and electrical products have always been one of the key points of foreign trade in Ningbo. As a downstream user of the chemical industry, there is no electromechanical company that trades with Europe
Enterprises are exempt from the REACH regime. The draft REACH regulation imposes obligations on producers and importers of chemicals and other tangible products entering the EU market to:
(a) Collate and submit a detailed report (i.e., "registration") including test data for each chemical substance contained in the product. In the REACH regulation, the scope of registration of chemical substances mainly includes:
1. Quantity ≥ 1 ton/year/person of independently existing substances or substances in preparations;
2. Monomers or other substances in polymers in the form of monomericunits or chemically bound substances in the form of monomericunits or chemically bound substances that are not registered in the upstream supplier with a content (weight ratio) of ≥% and a total amount of ≥2 tonne/year/person;
3. Substances in articles with a total amount > 1 ton/year/person and would be intentionally released under normal or reasonably foreseeable use;
4. If the total amount is > 1 tonne/year/person, the Chemical Bureau may request registration of substances in articles that have reason to suspect that they will be released from articles and that are harmful to humans or the environment.
In the REACH regulation, the substances exempted from registration are:
1. 1 ton/year/person of substance
2. Radioactive material
3. No processing or processing under customs supervision: (1) temporarily stored for re-export, or in bonded areas or bonded warehouses; or (2) transit
4. Non-separated intermediates
5. Means of transport for the transport of dangerous substances
6. Waste
7. Member States are exempt for reasons of national defense
8. Medicine or veterinary drugs
9. Additives, food flavorings and animal nutrition agents in food or feed
10. Substances in Annex IV (known to have a low risk)
11. Substances in Annex V
12. Re-import of a substance in the registered substance itself or in the product
13. When the registered substance itself, the product or the substance in the article is reprocessed (recovery process)
14. Polymers (polymers themselves) (except for monomers or other substances in polymers in the form of monomericunits or chemically bound substances that are not registered in upstream suppliers with a content [weight ratio] of ≥ 2% and a total amount of ≥ 1 tonne/year)
15. Chemical substances used only for product or R&D (PPORD) (5+5/10 years)
16. Co-formulants used only in crop protection products (considered registered)
17. Active ingredients used only in biocides (considered registered)
18. Substances that have been declared as new chemical substances under Directive 79/831/EEC (considered registered)
(2) Evaluate the safety factor of each chemical substance contained in the product ("chemical safety assessment").
The contents of the assessment are:
1. File evaluation is to verify the completeness and consistency of the registration files submitted by the enterprise.
2. Substance assessment is to verify whether the substance requires further information from the enterprise.
3, the evaluation mainly includes Dossier Evaluation and substance Evaluation. Dossier Evaluation includes:
--. The European Chemicals Agency must provide the registration information and completeness check report of the registrant to the competent authority of the Member State within 3 weeks of registration. However, registration files received within 2 months before the phased registration deadline will be reviewed within 3 months;
--. Non-phased registration of substances and phased registration substances that have passed the registration deadline are prohibited from being produced, sold, used and imported in EU countries until the examination is not passed (review of the technical dossier by the competent authorities of the Member States: assessment of the conformity of the registered technical documentation with the provisions of the regulations and inspection of animal testing programmes to avoid unnecessary animal testing);
--. EU member states review the submitted test drafts and draft relevant resolutions. The resolution reads as follows:
(1) Agree to conduct the experiment and submit a summary of the experimental results and a constructive analysis of the research methods within the deadline (specified in Annex I).
(2) Resolution is the same as a, but requires that it be carried out under revised test conditions.
(3) Resolution is the same as A, B or D, but when the test objectives submitted are inconsistent with the requirements of the annex, one or more additional tests are requested.
(4) Rejection of the proposal for experimentation.
(5) Resolution with A, B, or C, if several registrants submit the same trial proposal, the Authority shall coordinate within 90 days to reach an agreement to find one to conduct the trial to represent the whole.
(6) Agreed experiments shall have a publicity period of 45 days.
Substance evaluation includes:
--. The Authority provides Member States with criteria for the assessment of priority substances;
--. The draft evaluation rolling plan will be available on December 2011, 12, and thereafter by February 1 of each year;
--. Member States select substances from these to develop a rolling three-year evaluation plan and conduct assessments;
--. The Authority will post the final assessment checklist online;
--. EU Member States are required to draft a resolution (180 days for new substances) within the prescribed deadline for further information.
(3) Obtaining special authorization for use according to the different properties of chemicals.
The registration aspect of the REACH Directive stipulates that only EU companies can register. If a Chinese enterprise wants to register in the EU, it has to choose an EU agency, and the actual costs include agency fees, testing fees, registration fees, etc. It is generally estimated that the basic test cost of each chemical substance is about 8,5 euros, and the cost of testing each new substance is about 57,<> euros. The increase in the cost of the chemical industry is bound to cause a chain reaction in the downstream industry. As a result, the export situation of mechanical and electrical enterprises, which already did not have much profit margin, is even less optimistic.
Inspection and quarantine authorities remind relevant manufacturers to attach great importance to the huge impact that the implementation of REACH regulations may bring, and producers and operators must establish the concept of green production and green marketing. Take countermeasures as soon as possible, further track and understand the progress of legislation, import, research and development, use non-toxic and low-toxic products, apply for registration of chemical products exported to Europe, strengthen testing, timely reflect the technical barriers encountered, pay close attention to research and improve production, and ensure that risks are avoided. Only by continuously developing leading industries with independent intellectual property rights and being familiar with the rules of the WTO game can enterprises better avoid technical barriers to trade and avoid economic losses caused by the obstruction of export products to the greatest extent. If you want to win the market, you must improve the technical content of products, improve the awareness of intellectual property rights, continuously develop new products with market prospects, increase the development of environmentally friendly alternative materials, improve the quality of export products, and constantly adjust our production technology and product formula.
It should be noted that there are still many mechanical and electrical enterprises that do not know much about the new EU regulation. To this end, the inspection and quarantine department reminds mechanical and electrical enterprises: First, we must actively respond. Passive wait-and-see will miss the favorable opportunity, and enterprises can learn about the latest progress of the REACH system through relevant training and seminars. At the same time, the inspection and quarantine department will continue to release relevant information to enterprises. Second, we must take the initiative to understand. Enterprises should change the habitual thinking of relying solely on the guidance of government departments in the past, learn information through various channels such as industry associations, EU customers, agents, foreign institutions, etc., expand news sources, and fully grasp relevant trends. Third, it is necessary to strike at the right time. Mechanical and electrical enterprises should pay close attention to the situation of upstream chemical enterprises responding to the REACH system, and do a good job in the selection of raw material suppliers in advance so as not to affect production.
Protecting human health and environmental safety is the common goal of all countries to achieve sustainable development. REACH regulation has unusual reference significance for the formulation of relevant environmental protection and trade management regulations in China. As far as enterprises are concerned, now that China has joined the WTO and the economy has been globalized, enterprises cannot only focus on the immediate goals without paying attention to the development of the international market. Although there are suspected technical barriers in the REACH regulation, with the improvement of environmental protection requirements in various countries, some polluting enterprises and products will be eliminated. Therefore, relevant enterprises must accelerate the adjustment of product structure, continuously improve product quality, improve environmental protection requirements, enhance product update capabilities, and pay more attention to international market dynamics, strengthen trade skills, and continuously improve international competitiveness.
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