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REACH certification

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  REACH is a European Union REGULATION concerning the Registration, Evaluation, Authorization and Restriction of Chemicals), which stands for Authorization and Restriction of Chemicals, is a chemical regulation system established by the European Union and implemented since June 1, 2007.
  It is a proposal for a regulation on the safety of the production, trade and use of chemicals. The regulation aims to protect human health and the safety of the environment, maintain and improve the competitiveness of the chemical industry in the EU, as well as the innovative capacity to research and develop non-toxic and harmless compounds, prevent market fragmentation, increase transparency in the use of chemicals, promote non-animal experiments and pursue sustainable social development. The REACH directive requires that all chemicals imported and produced in Europe must go through a comprehensive set of procedures, including registration, assessment, authorization and restriction, in order to better and simpler identification of chemical ingredients in order to ensure the environmental and human safety. The directive mainly includes registration, evaluation, authorization, restrictions and other major contents. Any commodity must have a registration file that lists the chemical ingredients and describes how they were used by the manufacturer and a toxicity assessment report. All this information will be fed into a database being built by a new EU agency, the European Chemicals Agency, in Helsinki, Finland. The agency will evaluate each dossier, and if chemicals are found to have an impact on human health or the environment, it could take more stringent measures. Depending on the assessment of several factors, chemicals may be banned or require approval for use.
  According to the introduction, unlike the RoHS directive, REACH covers a much wider scope, in fact it will affect almost all industries from mining to textile clothing, light industry, mechanical and electrical products and manufacturing processes. REACH requires manufacturers to register every chemical component in their products, about 30,000 of them -- and to measure the potential harm to public health. REACH established the idea that society should not introduce new materials, products or technologies if their potential harm is not known with certainty. Electromechanical products have been one of the major foreign trade in Ningbo area. As a downstream user of the chemical industry, there is not a single electromechanical trade to Europe
  Enterprises are exempt from the restrictions of REACH. The draft REACH regulation imposes the following obligations on producers and importers of chemicals and other tangible products entering the EU market:
  (I) Compile and submit a detailed report including test data for each chemical substance contained in the product (i.e. "Registration"). In REACH, the registration scope of chemical substances mainly includes:
  1. Independently existing substances or substances in products with quantity ≥1 ton/year/person;
  2. Monomers or other substances in polymers in the form of monomericunits or chemically bound substances with an unregistered content (by weight) of more than 2% and a total volume of more than 1 ton/year/person in upstream suppliers;
  3. Total amount > substances in articles 1 t/yr/person that are intentionally released under normal or reasonably foreseeable use;
  4. Total amount > 1 ton/yr/person, the Chemicals Agency may require registration of substances from articles from which the Agency has reason to suspect that the release may be harmful to human health or the environment.
  In the REACH regulation, substances exempt from registration are:
  1. Material of 1 ton/year/person
  2. Radioactive materials
  (1) temporarily held for re-export, or in bonded areas or bonded warehouses; Or (2) in transit
  4. Non-separating intermediates
  5. Conveyance of hazardous substances
  6. Waste
  7. Member States are exempt for reasons of national defence
  8. Medical or veterinary drugs
  9. Additives, food flavorings and animal nutrients in food or feed
  10. Substances in Annex IV (known to have very low risk)
  11. Substances in Annex V
  12. Re-importation of a registered substance itself or a substance in a product
  13. recovery process of the registered substance itself, product or substance in the article
  14. Polymers (polymers themselves) (except monomers or other substances present in polymers in the form of monomericunits or chemically bound substances with an unregistered content [by weight] of at least 2% and a total volume of at least 1 t/yr from upstream suppliers)
  15. Chemicals for product or R&D use only (PPORD) (5+5/10 years)
  16. Only active ingredients and excipients in plant protection products (co-formulants) (deemed to be registered)
  17. Use only for active ingredients in biocides (deemed registered)
  18. Substances for which a new chemical substance declaration has been made under Directive 79/831/EEC (deemed to be registered)
  (b) To assess 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 check the integrity and consistency of the registration files submitted by enterprises.
  2. Substance assessment is to check whether the substance needs further information from the enterprise.
  3. Evaluation mainly includes Dossier Evaluation and substance Evaluation. Dossier Evaluation includes:
  The European Chemical Agency shall, within 3 weeks after registration, provide the competent authority of the Member State with the registration information and the integrity check report of the registrant. However, registration files received within 2 months prior to the deadline for phased registration will require 3 months for review;
  --. The production, sale, use and import of non-phased registered substances and phased registered substances after the registration deadline shall be prohibited in the EU countries before they have passed the examination (the competent authorities of the member States shall review the technical files to assess whether the registered technical documents comply with the provisions of the regulations and check the animal testing plans to avoid unnecessary animal testing);
  Eu Member States review the submitted draft tests 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 study methods within the deadline set out in Annex I.
  (2) The resolution is the same as A. but requires that the test be carried out under revised conditions.
  (3) The resolution is the same as a, b or d, except that one or more additional tests are required when the submitted test objective is inconsistent with the annex requirements.
  (4) Reject the proposal of experiment.
  (5) Resolution a, b or c, if several registrants submit the same test proposal, the Authority shall, within 90 days, coordinate their agreement to find one to conduct the test to represent the whole.
  (6) Approved experiments shall have a 45-day publicity period.
  substance Evaluation includes:
  The Authority provides member States with criteria for assessing priority substances;
  A draft rolling plan for evaluation will be provided by 1 December 2011 and thereafter by 28 February each year;
  Member States shall develop a rolling three-year evaluation plan for selected substances and conduct the evaluation;
  The authority will post the final assessment list online;
  Member States are required to draft a relevant resolution within a specified period (180 days for new substances) requesting further information.
  (3) Obtaining special authorization for the use of chemicals according to their different properties.
  The registration aspect of the REACH directive stipulates that only EU enterprises can register. If Chinese enterprises want to register in the EU, they have to choose the EU agency, the actual costs include agency fees, testing fees, registration fees and so on. Common estimates put the cost of a basic test for each chemical at around €85,000, and for each new substance at around €570,000. The increase in the cost of chemical industry is bound to cause a chain reaction of downstream industries. Make the original has not much profit space of mechanical and electrical enterprises, the export situation is not optimistic.
  Inspection and quarantine institutions to remind the relevant production enterprises to attach great importance to the implementation of REACH regulations may bring huge impact, producers and operators must establish the concept of green production, green marketing. We should take countermeasures as soon as possible, further track the progress of legislation, import, develop and use non-toxic and low-toxic products, apply for the registration of chemical products exported to Europe, strengthen testing, timely reflect the technical barriers encountered, accelerate research and improve production, and ensure that risks are avoided. Only by constantly developing the leading industry with independent intellectual property rights and being familiar with the game rules of WTO, can enterprises avoid the technical barriers to trade better and avoid the economic losses caused by the blockage of export products to the greatest extent. To win the market, it is necessary to improve the technical content of products, improve the awareness of intellectual property rights, constantly develop new products with market prospects, increase the development of environmental protection alternative materials, improve the quality of export products, and constantly adjust their own production technology and product formula.
  It should be noted that there are still many mechanical and electrical enterprises know little about the new rules of the European Union. To this end, inspection and quarantine departments to remind mechanical and electrical enterprises: a positive response. Passive wait and see will delay the favorable opportunity. Enterprises can learn the latest progress of REACH system through relevant training and seminars. At the same time, inspection and quarantine departments will continue to release relevant information to enterprises. Second, take the initiative to understand. Enterprises should change the traditional 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 and foreign institutions, expand sources of information, and fully grasp relevant developments. Third, timely attack. Mechanical and electrical enterprises should pay close attention to the upstream chemical enterprises to cope with the REACH system, and do a good job in selecting raw material suppliers in advance so as not to affect production.
  Protecting human health and environmental security is the common goal of all countries to achieve sustainable development. REACH regulations for our domestic development of relevant environmental protection, trade management regulations, has an unusual reference significance. For enterprise, now our country has joined WTO, the economy has been globalized, enterprise can not only pay attention to the current target, but not pay attention to the development dynamics of the international market. REACH is suspected of technical barriers, but with the improvement of environmental protection requirements in various countries, some polluting enterprises and products will be eliminated. Therefore, relevant enterprises must speed up the adjustment of product structure, constantly improve product quality, improve environmental protection requirements, enhance the ability of product renewal, at the same time should pay more attention to the international market dynamics, strengthen trade skills, and constantly improve international competitiveness.

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