Author of the book: Dr. Chen Qingjin, International Certification Service Department, SGS-CSTC Standards Technical Services Co., Ltd.
Chapter 1 REACH Overview and Terms and Definitions
Section 1 Introduction
"REACH" is the abbreviation of the European "Registration, Evaluation, Authorization and Restriction of Chemicals" regulations. Its true full name should be "Registration, Evaluation, Authorization and Restriction of Chemicals, established by the European Parliament and the Council of the European Union on December 18, 2006" European Chemicals Agency, amending Directive 1999/45/EC, canceling Council Regulation No. 793/93, Commission Regulation No. 1488/94 and Council Directive 76/769/EEC and Commission 91/155/EEC, 93/ 67/EEC, Regulation 93/105/EC and Directive 2000/21/EC No. 1907/2006".
Judging from the nature of the regulations, this is a regulation, not an instruction that everyone is relatively familiar with. The difference between the two is that EU regulations do not need to be converted into individual member state regulations before they take effect. They take effect directly in each EU member state; directives must first be converted into individual member state regulations before they take effect.
REACH is a comprehensive regulation on chemicals management. Some people believe that it is "the most complex foreign technical barrier with the widest impact that our country has ever encountered." Judging from the complexity of regulations and the scope and degree of impact on the industry, this statement is indeed true! However, don’t think that REACH only brings technical barriers to enterprises. In fact, it also has advantages for enterprises outside the EU. To sum up, it can be considered that it will do more harm than good to the chemical industry outside the EU, and for general article manufacturing companies outside the EU, it can be considered that the good will outweigh the harm. Only by truly mastering REACH requirements and responses can we turn disadvantages into advantages, avoid possible huge losses, and seize market opportunities.
The regulations came into effect on June 1, 2007. You may think that it has been almost two years since the regulations came into effect, and it does not have much impact on you. Customers have not made any requirements. Exports are still going on normally. Is it a very important regulation? Fool us? This feeling is of course wrong and very harmful. There are several reasons why the impact on the industry has not been as dramatic as the RoHS Directive. First, companies have already had experience in dealing with hazardous substances restriction regulations such as the RoHS Directive. The overall feeling is that such regulations tend to be louder than rainy. Second, due to the comprehensive impact of the current economic crisis, many companies are considering survival issues and have no intention of taking the initiative to respond. Third, the different requirements related to REACH regulations and companies are gradually taking effect, and many REACH-related requirements are only now gradually taking effect. Enterprises cannot take chances and respond proactively.
Judging from the content of the regulations, although the original English text of the regulations has 849 pages and the English version of the relevant guidance documents is about 6,000 pages, if we want to simplify the problem, for enterprises, the requirements of REACH can actually be summarized as follows In one sentence:
“Control requirements for substances (chemicals) in products.”
Although this sentence is very simple, it has extremely rich connotations. There are three key words: product, substance, and control requirements.
Products: In the REACH regulations, all products are divided into three categories - substances, preparations, and articles. For these three categories of products, the REACH regulations have different requirements.
Substances: There are different types of substances, including free active states and fixed inactive states, hazardous substances and non-hazardous substances, and the quantities exported to the EU are different. For these different substances, REACH has different requirements. Please note that the various requirements of REACH are basically aimed at the substances contained in the product, not the product itself. A very small number of requirements also target preparations, such as SDS production and delivery requirements for hazardous preparations and restrictions on hazardous preparations.
Control requirements: When substances of different types, states, properties and quantities are in different products, their corresponding REACH requirements are different. All in all, the greater the risk a product poses to humans or the environment due to the combined effect of these factors, the stricter the control requirements imposed by REACH regulations. REACH requirements related to enterprises include pre-registration, registration, registration inquiry, registration update, receiving registration evaluation, applying for substance use authorization, notification of substances of very high concern, information communication within the supply chain, restrictions on hazardous substances/preparations, substance classification and Label notification, etc. These requirements may have different applicability to different businesses. There are dedicated chapters below for discussion.
In addition, this is an EU regulation, and the objects it directly regulates can only be natural persons and legal persons in the EU (REACH regulations also apply to Norway, Liechtenstein, and Iceland, which are non-EU members), but not natural persons outside the EU. and legal persons. In other words, the REACH regulations do not require companies outside the EU to comply with the relevant provisions of REACH. The reason why companies outside the EU, including domestic companies, must consider the requirements of REACH regulations is because their customers in the EU need to meet the relevant requirements of REACH regulations, and in order to meet these requirements, customers need the cooperation of manufacturers outside the EU, such as providing Necessary information to ensure that hazardous substances in products do not exceed standards, etc. This should be a basic concept, but many companies still lack basic understanding of it. It needs to be made clear here that the specific operation methods suggested by regulations are not necessarily mandatory requirements. For example, REACH stipulates that registration can be carried out by companies outside the EU designated by the "only representative" in the EU, but REACH does not require companies to find a "sole representative" in the EU. The sole representative" is responsible for registration. The direct responsibility for registration lies with the importer.
The range of products to which regulations apply is a complex topic. REACH has a very broad scope of application, covering all substances, whether they are manufactured in the EU, imported from the EU, used as intermediates in the EU, or put on the EU market, whether they are the substance itself or preparations or articles Substances in the country, unless they are: Radioactive substances l Substances subject to customs control l Non-isolated intermediates l Waste l Substances exempted for defense purposes at the EU Member State's own discretion l Substances in transport l The European Commission will notify the EU five days after the entry into force of the regulation Annual review of the scope of regulations. The different requirements of the REACH regulations, such as (pre-)registration, application for authorization, notification of substances of very high concern, information transfer, restricted hazardous substances, etc., each have their own product scope covered, which are introduced in the corresponding chapters of this book.
It must be emphasized here that the scope of substances covered by the REACH regulations is not only the "chemical" products mentioned in the title of the regulations, but all chemical substances. Many companies think that REACH regulations are only requirements for the chemical industry, and ignore the impact that REACH regulations may have on their own companies. To avoid misunderstandings, we might as well understand "chemicals" as "chemical substances". Any product is composed of chemical substances. In theory, any product is within the scope of REACH regulations, except for the above-mentioned six categories that are specifically exempted by REACH.
Of course, a simple concept here needs to be clarified. As an EU regulation, REACH only regulates products entering the EU market, including products that directly enter the EU market, products that enter the EU after being transferred to a third place, and products that are used in customer products. , products that will eventually enter the EU. If a company's products are only sold in markets outside the EU, and the products will never enter the EU directly or indirectly through any means, such products do not need to consider REACH requirements.
Penalties for violating REACH generally include fines, imprisonment, recalls, delisting and other measures. For example, the United Kingdom stipulates that violation of REACH provisions may result in fines or even imprisonment for up to 2 years; the Netherlands stipulates that violation of REACH provisions may result in penalties of up to 670,000 euros or even 6 years in prison; France stipulates that violation of REACH may result in administrative penalties or criminal penalties; Germany stipulates that violation of REACH may result in administrative penalties or criminal penalties. A fine may be imposed, and a concurrent or separate prison sentence of 1 to 5 years may be imposed. |
