I. Introduction to reach test in EU
Reach in EU refers to "chemical registration, assessment, licensing and registration", which is the abbreviation of registration, Evaluation Authorization and restriction of chemicals. It is a chemical management law of EU for preventive management of all chemicals entering its market. It is similar to the registration, authorization and license system of special products (commercial products). It completely transfers the burden of proof of chemical safety information to enterprises, and advocates that "there is no market without data". In February 2001, the European Union published the white paper of future chemicals policy strategy; in May 2003, it published consultation documents for public consultation; in October 2003, it finally formed the reach regulation proposal and submitted it to the Council of Ministers for discussion; in November 2005, reach passed the first reading; on December 13, 2006, the European Parliament passed the second reading proposal of reach regulation by 529 votes in favor, 98 votes against and 24 abstentions; rea Ch regulation will come into force on June 1, 2007 and come into force on June 1, 2008.
II. EU reach system requirements
(1) registration: it is required to register the basic information of all existing chemicals and new chemicals with an annual output of more than 1 ton and chemical substances applied in various products. For chemicals and chemical substances with an annual manufacturing or import volume of more than or equal to 10 tons, chemical safety assessment shall be conducted and safety report shall be completed.
(2) evaluation: evaluation includes file evaluation and material evaluation. The file evaluation includes the examination of test draft and the examination of registration compliance; the examination of test draft requires the registrant or downstream users with annual production of more than 100 tons to submit the test draft and give priority to the handling of PBT, vpvb and other substances with annual production of more than 100 tons; the examination of registration compliance is to spot check 5% of the files within the range of each ton and examine whether the submitted materials meet the requirements of laws and regulations.
(3) authorization: the authorization of chemicals with certain hazardous characteristics that attract people's high attention, including CMR (all class 1 or 2 carcinogens, mutagenic substances or substances harmful to reproduction), PBT (persistent, bioaccumulative and toxic substances), vpvb (very persistent, highly bioaccumulative substances), etc.
(4) restriction: if you think that
If the risks to human health and environment caused by the manufacturing, putting on the market or using of the substance itself, configuration products or products cannot be fully controlled and need to be pointed out at the community level, the committee or a member state shall submit a file, and the risk assessment committee and the socio-economic analysis Committee shall clarify the suggestions on restrictions on the basis of considering the relevant parts of the file respectively The European Commission shall make a final decision according to relevant procedures.
III. substance type of reach regulation of EU
According to the reach regulation of the European Union, substances can be divided into three types: substance itself, substances in mixtures and substances in articles. The reach regulation of EU has a complete registration and evaluation system, involving about 30000 chemicals, covering almost all products exported to EU (except food, medicine and pesticide). In response to the requirements of SVHCs in the reach regulation of the European Union, each link in the supply chain shall bear corresponding obligations:
IV. current trend of EU REACH Regulation
SVHC (substances of very high concern) is a substance with the following characteristics:
(1) carcinogenic, mutagenic and reproductive toxic, 1,2 classes;
(2) persistence, bioaccumulation and toxicity;
(3) high persistence and bioaccumulation;
(4) substances with the same impact (such as endocrine disruptors).
The reach regulation of the European Union involves not only chemical manufacturers, but also importers, downstream industries and many other fields, including light industry, mechanical and electrical industry and textile industry, which are widely used in chemicals. So far, it has been listed as 173 SVHC candidate substances.
After the implementation of the EU REACH regulation, it is estimated that about 30000 substances (including intermediates) need to be registered. The European catalogue of existing commercial chemicals (EINECS) is published in the government Journal of the European Community and can also be found on the homepage of the website of the European Chemicals administration. All chemicals with a production capacity of more than 1 ton have been included in the catalogue. In addition to the chemicals in this catalogue, only those chemicals that produce or import more than one ton need to be registered. In addition, the European chemical information system (esis) has a high yield low yield list, which may be a good list of substances on the market with a quantity of 10 tons or more per year and need to be registered, which can be viewed on the website of the European chemical administration.