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The EU" about chemicals registration, evaluation, authorization and restriction of" ( REACH code) was in December 18, 2006 by the Council of the European Union 's final vote, and has been officially promulgated, will be in June 1, 2007 to begin full implementation.
REACH replaces the current 40 regulations, become a unified set of chemicals registration, evaluation, authorization and restriction of administrative laws and regulations. It has a set of perfect registration and assessment system, involving about 30000 chemicals, require years of production or import volume reached or exceeded 1 tons in all" current" or" new" chemicals are registered, in order to provide the relevant safety information.
REACH involving almost all ( in addition to food, medicine, pesticides) export products to the eu. How to face the challenge? How to deal with the REACH registration, notification, licensing and limitation? Is expected over the next few years, will face a lot of material safety data sheet ( SDS ), how to judge whether the SDS meets REACH requirements?
The purpose of REACH
The protection of human health and the environment; to maintain and improve the European chemical industry competitiveness; increased chemical information transparency; reducing vertebrate animal testing; and the European Union in the framework of WTO international obligations congruent.
From substantial sense, REACH regulations will promote the chemical industry innovation, make the production safer products, competition and growth stimulation. With the complicated law system different, REACH will within the European Union to create a uniform chemical management system, enables companies to follow the same principles of production of new chemicals and products thereof.
The main content of REACH
Register ( Registration ) annual production or import volume of more than 1 tons of all of the chemical substances and the need for registration, annual production or import volume of more than 10 tons of chemical substances shall also submit the chemical safety report.
Assessment (Evaluation ) including archives evaluation and substance evaluation. Dossier evaluation is the enterprise to submit the registration dossier for completeness and consistency. Substance evaluation refers to the confirmation of chemical material harm to human health and environmental risks.
Licensing (Authorization) with certain risk characteristics and cause people to attach great importance to the chemical production and import license, including CMR, PBT, vPvB etc..
Limit ( Restriction ) if you think a substance or its products, manufacture, market or use lead to risks for human health and the environment cannot be adequately controlled, will limit their production or import in the eu.
Note: the PBT persistence, biological accumulation and toxicity of chemicals
VPvB high durability, high biological accumulation of chemical substances
CMR carcinogenicity, mutagenicity and biological toxic material
REACH system influence on China export trade influence
A wide range of influence, industry: in addition to the chemical enterprise has direct influence, REACH will include textile, mechanical and electrical, toys, furniture and all the production of downstream chemical products business impact, the product has about 1000000 kinds.
Two, export costs increased significantly: according to EU estimates, each kind of chemical basic testing costs about 85000 euros, each kind of new material testing costs about 570000 euros.
Three, the large amount of data : the REACH is required to provide chemical safety data sheet, safety assessment, risk assessment and a series of registration archives technical file, the data amount of complex.
REACH registration flow chart
For more than 1 tons of annual production of all existing chemicals and new chemicals and used in a variety of products in the chemical substances registration basic information. Only through the registration of material to the production or import.
Every material manufacturers and importers are required to submit the material chemical management department registration dossier, and pay the corresponding expenses. But the joint submission of the same substance registration information, i.e., follow the "one matter, one registration". As a registered member, can be associated with other members to share registration fee.
In order to ease of administration, to accept large register file submission, submitted to the Agency registration archives need electronic processing. Chemical management department will give each received the registration files a registration number and date of registration, and immediately communicates this information to the registrant.
In the submission of the registration documents after three weeks, the agency will submit registration documents as an integrity verification, to determine the file with REACH registration requirements. If registration is not complete, the agency will be in the registration date of three weeks notice, registration within the prescribed time limit to submit further information, to complete the registration file.
For phase-in substances, provides pre registration procedures. Through the preliminary registration of material, can continue in the European Union are in production and sales, as long as the deadline through formal registration.
For phase-in substances, in the period a large number of registered need to complete. Therefore, the agency for each registration, need in 3 weeks to check registration information is complete; but in the end within 2 months before the date of submission for each register, the EU will within 3 months to check registration is complete.
People need the registration within the set deadline an updated dossier to the agency, require the submission of the missing information. The agency then confirms the submission date of this information, within 3 weeks of receipt of the updated file to check their integrity.
If the registrant fails to complete his registration within the set deadline, the registration will be rejected by the agency, the manufacturer or importer is not allowed to start or continue manufacture or import of the substance.
If necessary, the agency will forward the registration, the registration number and date, integrity of the inspection results to the member authorities, manufacturers and importers established to enable enforcement action. Incomplete files to submit supplemental information, together with the second integrity checking results submitted to the competent authorities.
Assessment of Evaluation
The first objective: administration assessment industry testing to ensure product safety, and to ensure that minimize or avoid animal testing.
Second objective: to check whether they meet the registration requirements.
Third objective: to check the matter on human health and the environment harm.
Assessment for the authorities to provide a series of methods to require registrants, and a few of the downstream users, to provide further information.
There are two types of evaluation: dossier evaluation and substance evaluation.
Dossier evaluation: management authorities to check the test purpose, to avoid unnecessary animal testing and cost, at the same time check register file with the registration requirements.
Substance evaluation: when to suspect a matter on human health and the environment are exposed when the risk ( such as with another substance has a similar structure ), management of substance evaluation. Therefore, the same material all the technical archives will be evaluated together, any useful information is taken into account.
REACH suggested the establishment of a system to manage the use of substances of very high concern, make it into the market to meet the requirements of administration.
Management requirements of material and use of effective information are taken into account, to confirm which material generated in using risk can be fully controlled or its economic benefits outweigh the risks.
On human health have irreversible effects on the first and the second kind of substance CMR, available in a biological organism accumulation of PBT and substance vPvB are substances of very high concern. Evaluation system build a safety net for the other, and CMR, PBT and vPvB material with the same hazard and irreversible effects of substances, each identification.
Management requirements under the frame of REACH of substances of very high concern must be in before the deadline, for each application for permission to use every time, regardless of how much is.
The applicant has the obligation to prove the material risks can be adequately controlled or its economic benefits outweigh the risks. In addition, the applicant must submit the material substitute development plan and the social - economic analysis report.
Through the agency risk and Social Economics Analysis Committee for review, the final decision whether to license this substance use.
Substance information exchange forum ( SIEF ) for phase-in substances experimental information is easily obtained, it will result in the same time many potential registrants to the registration of the same material, in order to facilitate the same material the potential registrant information sharing, the EU requirements phase-in substances pre-register, take the opportunity to learn the same material number the potential registrant to register, and the same material the potential registrant substance information exchange forum ( Substance Information Exchange Forum