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Overview of reach regulation in EU
The full name of reach regulation is "registration, evaluation, authorization and restriction of chemicals", i.e. the registration, evaluation, authorization and restriction of chemicals. It is a European Union regulation on the preventive management of all chemicals entering its market. The regulation came into force on June 1, 2007 and came into force on June 1, 2008. According to the EU REACH regulation, an enterprise shall submit to the European chemical Administration (ECHA) for registration of chemical substances (substances themselves, substances in mixtures or substances intentionally released from articles) with an annual production or import volume of more than 1 ton in the EU, otherwise the enterprise will not be able to continue to manufacture, import or sell the chemicals within the EU. In addition, the laws and regulations on some registered substances also stipulate the obligations of continuous evaluation, notification / authorization and restriction.
Under the reach regulation of the European Union, the core content of jurisdiction mainly involves the following aspects:
Classification of chemicals
Under REACH regulation, chemicals are divided into three categories: substances, mixtures and articles.
Substance: refers to the chemical elements and their compounds obtained in the natural state (existing) or through the production process, including additives necessary to maintain their stability and impurities produced in the processing process, but excluding the separable solvents that will not affect the stability of the substance or change its components.
Mixture: a mixture or solution consisting of two or more substances. The mixture is obtained by the producer according to a certain proportion of artificial mixing, such as color masterbatch, auxiliary masterbatch, etc.
Article: refers to an object that obtains a specific shape, appearance or design in the manufacturing process. These shape, appearance and design chemical composition can better determine its function.
Corresponding obligations
• substances in substances or preparations
Under the reach regulation, all enterprises that produce or import chemicals greater than 1 ton / year in the EU need to register the chemicals they produce or import with the EU chemicals administration.
The first step is pre registration or post pre registration or inquiry; the second step is formal registration.
Pre registration or post pre registration are for phased substances, only a small amount of information needs to be submitted to ECHA, which is much simpler than formal registration. The pre registration period given in reach regulation is from June 1, 2008 to November 30, 2008. After that, enterprises can determine whether they can carry out post pre registration according to the post pre registration conditions given in reach regulation. The post pre registration period is from December 1, 2008 to May 31, 2017. Enterprises can choose (after) pre registration to enjoy a certain buffer period, and then determine whether to conduct formal registration according to the trade situation at the end of the buffer period. Pre registration and post pre registration are only conducted at different times, and they play the same role under the reach regulation.
The inquiry is applicable to all non phased substances and phased substances not pre registered or post pre registered before June 1, 2017. The query is more complex than pre registration or post pre registration. It needs to make a query file and submit it to ECHA, including basic material identification information, material identification spectrum, etc.
Pre registration, post pre registration and inquiry are all prerequisites for formal registration. To make formal registration for any substance, one of pre registration, post pre registration or inquiry must be selected according to corresponding conditions.
Formal registration requires the preparation of a formal registration file, including the identification information, physical and chemical data, toxicology data, ecological toxicology data, etc. it is a work that requires a lot of human, material and financial resources.
• phased substances
Substances included in the EINECS (European list of existing chemicals, currently including 100106 chemicals);
Within 15 years prior to the entry into force of reach regulation, substances that have been manufactured but have not yet been put on the market in the European Community countries or countries that entered the European Union in May 2004 and January 1, 1995;
Substances listed in NLP (no-long polymer)
• non phased substances
Substances that do not belong to the definition of phased substances are either non phased substances or new substances.
Articles
Since the article may contain substances of high concern (SVHC) given by reach regulation, it is required to undertake the obligation of conformity assessment, that is, the articles within the EU or imported to the EU market need to undergo SVHC test to determine whether SVHC substances are contained in the articles, and determine the subsequent response steps according to the test results.
If the article contains SVHC substance, and the annual export volume of the substance exceeds 1t, and the content exceeds 0.1% of the product as a whole (both conditions need to be met at the same time), and the product meets the requirements of the notification, the enterprise must notify ECHA.
If the articles contain intentional release substances (such as air fresheners and erasers), and the amount in the articles is more than 1 ton / year, this part of substances shall also bear the obligation of (pre) registration.
Reach supply chain compliance system - newrsc
Newrscc, independently developed by ruiou, is an online application system based on the comprehensive security network database - the new reach supply chain compliance system (newrscc), which can effectively help solve the communication of reach compliance issues between enterprises in the product supply chain. The system is responsible for the management, storage and transmission of tonnage coverage information and reach compliance documents of non EU enterprises' trade with Europe. The new generation of tools has a good system interface, simple operation process and strict confidentiality mechanism. Ensure the timely communication between non EU manufacturers, distributors and EU importers, meet the reach compliance requirements on the supply chain, and ensure the safety of information in transmission and storage.
REACH query
According to the EU REACH Regulation: the substances produced or imported by the enterprise belong to new substances (substances listed on the EU market after 1981). From June 1, 2008, the enterprise can continue to legally engage in the production or import of the product only after completing the formal registration of the reach regulation. However, before the formal registration, the enterprise must first query. The substances produced or imported by the enterprise belong to phased substances, which need to be submitted to reach pre registration or late pre registration between June 1, 2008 and May 31, 2017. If the enterprise misses the pre registration or late pre registration, it must carry out inquiry according to the requirements of laws and regulations before it can carry out formal registration.
Query means to submit the basic material identification information, component information, process description and material identification spectrum to ECHA for official judgment of the identity of the substance, so as to match the joint registered substance and the joint registered member. For non phased substances, the available data node information can also be obtained through query.
What products need to be done?
Exports to the EU of substances, preparations and intentional release of substances in articles over 1 ton / year.
The industries involved mainly include chemical, mineral, metal, medicine, daily chemical products and other fields.
Which enterprises need to do?
Export enterprises without pre registration of phased substances (post) before June 1, 2017;
Export enterprises of non phased substances.
REACH registration
Reach registration scope
More than 1 ton / year of chemicals put on the EU market;
More than 1 ton / year of chemical components in the preparations put on the EU market;
Intentional release of chemicals into the EU market, with a total amount of more than 1 ton / year.
Note: substance intentionally released from an article: substance intentionally released from an article under normal or reasonably foreseeable use, usually in order to achieve some auxiliary function of the article, such as air freshener.
Reach registration subject
Manufacturers of substances, accessories and articles within the EU;
Importers of substances, accessories and articles within the EU;
Manufacturers of non EU substances, accessories and articles must fulfill the registration obligations required by the EU REACH regulations through the only representative (or) within the EU.
Reach registration type
According to whether the substance is an intermediate, reach registration can be divided into two types: SCC intermediate registration and conventional registration.
Reach registration process
Reach registration schedule
Note: phased substances (existing substances) are listed in the European Union EINECS, NLP list, and substances produced in the European Union after 1992 but not put on the market; in addition, they are non phased substances (new substances).
Obligations other than reach registration
All enterprises that produce or import more than 1 ton / year of chemicals within the EU need to register the chemicals they produce or import with the EU chemicals administration. Any substance that may pose a risk to human health or the environment will be officially assessed and even included in the authorization / restriction list.
| Assessment |
|
| Bulletin | List of authorization candidates Object: substance in the article, content > 0.1% (mass percentage) and total amount ≥ 1t / A Work: report within 6 months after listing; transfer safe use instructions; material / mixture / article transfer safety data sheet (SDS) |
| To grant authorization | Authorization list (Annex XIV) Object: substance or mixture Job: submit authorization application Period: latest application date (before which the application can enjoy the buffer period); sunset date (after which the unauthorized substances are not put on the market) |
| limit | List of restrictions (Annex XVII) Objects: substances; substances in mixtures; substances in Articles Result: restricted or prohibited |
How to deal with it?
Enterprises can have the following three ways to deal with it：
| Set up branch in EU | The establishment of a branch company in the EU is conducive to the control of product confidential information, and it can also control the whole supply chain of its products exported to the EU, which has certain trade advantages, but the cost is too high, involves the most links, and has a long cycle. |
| Commission importers in the EU | The domestic enterprises do not need to study the complex reach regulations when they entrust the importers in the EU, but they may face many additional conditions in the trade negotiation process, and they are at a disadvantage in the negotiation process. They openly disclose their product information to the importers, resulting in the leakage of core technologies and documents. The importers are relatively fixed and easy to be controlled by each other in long-term trade. |
| Or (only representative) | Entrusting a third party to register, the cost is relatively low, the agency has a strict confidentiality system, and there is no peer competition with the entrusting party; the enterprise can respond to reach laws and regulations in a timely, fast, correct and professional manner to avoid the impact on production and trade. According to the data at present, this coping style is the most economical, reliable and effective. |
What is the lead registrar?
The leading registrant in reach regulation is called lead register (LR). When multiple registrants register the same substance, in order to ensure one substance and one dossier, one registrant shall obtain the consent of other registrants and submit the core data of the dossier on their behalf, i.e. classification label, physical and chemical properties, toxicology number According to ecotoxicological data, the registrant who plays this role is the lead registrant.
What kind of registrant can be the lead registrant?
In theory, there is no strict regulation on the leader registrant. Generally speaking, the following types of registrants are suitable for the leader registrant:
Companies with material data. Some famous international companies, such as BASF, Clariant, IFF, Firmenich and so on, have many products and data, so they take the leading role as registrants and are recognized by many other registrantsRegistered consortium. Some large consortiums, such as ferrite consortia and fluorocarbon consortia, are composed of some large companies with strong intention of registration. Usually, a company will be selected as the lead registrant, and the registration process will be promoted by the consortia.
Large tonnage enterprises in the industry. Due to the high registered tonnage, these enterprises need to deal with reach registration as early as possible, and usually need to complete the registration before the first and second registration deadlines. Therefore, if no other data holder is willing to act as the lead registrant, these enterprises should actively act as the lead registrant.
Advantages of being a leading registrar
Among the registered substances, according to the information provided by the leading registrant, there are some substances with management fees of more than 200000 or even millions of euros, which are ultimately shared by many registrants, improving the response cost of the enterprise. Therefore, to become a leading registrant, the following objectives can be achieved:
Save money. It can greatly reduce the management costs paid by enterprises and help enterprises reduce unnecessary expenditures.
The new test data in the registration process may be sold for registration under other regulations in the future to recover the data cost.
Increase the influence of the enterprise in the global scope: there are a large number of international enterprises in SIEF members. By doing LR, the enterprise's strength and popularity in this product can be improved as a whole.
Should I be the lead registrar
To become a leading registrant, in addition to enjoying the necessary convenience, it also puts forward higher-level requirements for enterprises. Enterprises need to comprehensively measure the trade situation of the material: whether it occupies the leading position in the world, whether it is the company's fist product. In addition, we need to measure whether we can undertake the relevant upfront investment. Generally speaking, the total cost of completing the registration of 100-1000 tonnage is about 500000-1 million euros. Therefore, enterprises need to consider many factors, and carefully decide whether to become a leading registrant.
Common problem
Q: if the new substance is used as an intermediate, do you need to submit inquiry before registration?
Answer: submission of inquiry has nothing to do with the use of the substance. Therefore, whether it is used as an intermediate or not, it is necessary to submit inquiry to obtain feedback from ECHA before registration of intermediates under 1000 tons only requires free data.
Q: if the formal registration of the customer is entrusted to other ors, can we undertake the material authorization work? That is, whether the or of registration and authorization must be the same?
A: no matter whether the substance in Annex XIV has been registered or not, and whether or not the registration has been completed with or participation, non EU manufacturers can designate another or to apply for authorization. That is, authorization and registered or can be different.
Our service
Reach unique representative (or) service
Reach query service
Lead registration agent service
Test Supervision Service
PPORD notification service
Waiver production services
Transfer to OR service
SIEF management services
Reach registration service
Develop exposure scenario (ES) services
Chemical safety assessment development and chemical safety report (CSR) preparation service
Extended security data sheet (ESDs) authoring service
Third party technical support services
Supplier reach compliance review service
Supply chain reach compliance management platform services
EU reach law enforcement inspection response service
Article SVHC notification service
Application for authorization of substances and mixtures
Reach regulatory training services
Consortium support services
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