Author: Dr. Chen Qingjin, International Certification Services Department, SGS-CSTC Standards Technical Services Co., Ltd.
Chapter 1 Overview of REACH and Terms and Definitions
Section 1 Introduction
“REACH” is an abbreviation for the European Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals. Its full name is “Regulation 1907/2006 of the European Parliament and the Council of the European Union of 18 December 2006 concerning the registration, evaluation, authorization and restriction of chemicals, establishing the European Chemicals Agency, amending Directive 1999/45/EC, and repealing Council Regulation 793/93, Commission Regulation 1488/94, and Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.”
From the nature of the regulation, this is a regulation, rather than the more familiar directive. The difference between the two is that EU regulations do not need to be transposed into individual member state regulations to take effect; they are effective directly in all EU member states. Directives, on the other hand, must be transposed into individual member state regulations before they take effect. REACH is a comprehensive regulation concerning the management of chemicals. Some consider it "the most complex and far-reaching foreign technical barrier China has ever encountered." Given the complexity of the regulation and the scope and extent of its impact on the industry, this is indeed true! However, one should not think that REACH only brings technical barriers to enterprises. In fact, it also has advantages for companies outside the EU. Generally speaking, it can be considered more harmful than beneficial to the chemical industry outside the EU, while for general goods manufacturing companies outside the EU, it can be considered more beneficial than harmful. Only by truly mastering the REACH requirements and how to respond can one turn disadvantages into advantages, avoid potential huge losses, and seize market opportunities. The regulation came into effect on June 1, 2007. Some may feel that the regulation has been in effect for almost two years and hasn't had much impact on them, with customers not making any demands and exports still proceeding normally—is it not a very important regulation? Are you trying to fool us? This feeling is certainly wrong, and extremely harmful. There are several reasons why it hasn't had the same dramatic impact on the industry as the RoHS directive: First, companies already have experience dealing with hazardous substance restrictions like the RoHS directive, and the general feeling is that such regulations are often more bark than bite; second, the current economic crisis has many companies focused on survival and lack the will to proactively address the issue; third, the various requirements related to REACH are taking effect gradually, with many REACH-related requirements only now becoming effective. Companies cannot afford to be complacent; proactive response is the right approach.
Looking at the content of the regulations, although the original English text is a hefty 849 pages, and the related guidance documents are approximately 6000 pages in English, to simplify the issue for companies, the REACH requirements can actually be summarized in one sentence:
“Control requirements for substances (chemicals) in products.”
This sentence, though very simple, is extremely rich in meaning. It contains three key words: product, substance, and control requirements.
Products: The REACH Regulation classifies all products into three categories—substances, preparations, and articles. Different requirements apply to these three categories.
Substances: Substances come in different types, including free and active forms and fixed and inactive forms; some are hazardous and some are non-hazardous; and the quantities exported to the EU vary. REACH has different requirements for these different substances. Note that REACH requirements primarily target the substances contained in the product, not the product itself. A very small number of requirements also apply to preparations, such as requirements for the preparation and transfer of SDS (Safety Specifications for Hazardous Preparations) for hazardous preparations, and restrictions on hazardous preparations.
Control Requirements: Different types, states, properties, and quantities of substances in different products have different corresponding REACH requirements. In summary, these factors work together to ensure that the greater the risk a product poses to humans or the environment, the stricter the REACH control requirements will be. REACH requirements relevant to businesses include pre-registration, registration, registration inquiries, registration renewal, acceptance of registration assessments, authorization for the use of applied substances, notification of substances of very high concern, communication within the supply chain, restrictions on hazardous substances/preparations, and notification of substance classification and labelling. The applicability of these requirements varies among different companies. This is discussed in a dedicated section below. Furthermore, this is an EU regulation, directly governing only natural and legal entities within the EU (REACH also applies to non-EU member states Norway, Liechtenstein, and Iceland), not natural and legal entities outside the EU. In other words, REACH does not require companies outside the EU to comply with its provisions. The reason why companies outside the EU, including domestic companies, need to consider REACH requirements is that their EU customers need to meet these requirements, and to do so, customers require the cooperation of manufacturers outside the EU, such as providing necessary information and ensuring that hazardous substances in products do not exceed limits. This should be a basic concept, but many companies still lack a fundamental understanding of it. It's important to clarify that the specific operational methods suggested by the regulations are not mandatory requirements. For example, REACH allows registration to be carried out by a company outside the EU designating a "sole representative" in the EU, but REACH does not require companies to have a "sole representative" for registration. The direct responsibility for registration lies with the importer. The scope of products covered by the regulations is a complex topic. REACH has a very broad scope, covering all substances, whether manufactured in the EU, imported into the EU, used as intermediates in the EU, or placed on the EU market, and whether they are the substances themselves, in preparations, or in articles, unless they are: radioactive materials; substances subject to customs control; non-separated intermediates; waste; substances exempted by EU member states for defense purposes; substances in transit; or substances for which the European Commission will review the scope of the regulations five years after their entry into force. Different requirements of the REACH regulations, such as (pre)registration, application for authorization, notification of substances of very high concern, information transmission, and restrictions on dangerous substances, each have their own product scope, which are introduced in the corresponding chapters of this book. It must be emphasized here that the REACH regulation covers far more than just "chemicals" as mentioned in the title; it encompasses all chemical substances. Many companies mistakenly believe that REACH only applies to the chemical industry, neglecting its potential impact on their own businesses. To avoid misunderstanding, let's understand "chemicals" as "chemical substances." All products are composed of chemical substances, and theoretically, all products fall within the scope of REACH, except for the six categories specifically exempted by REACH mentioned above. Of course, it's also necessary to clarify a simple concept: as an EU regulation, REACH only governs products entering the EU market, including products entering the EU directly, products entering the EU after being transferred to a third country, and products that will eventually enter the EU after being used in customer products. If a company's products are only sold in markets outside the EU and will absolutely not enter the EU directly or indirectly in any way, such products do not need to consider REACH requirements. Penalties for violating REACH generally include fines, imprisonment, recalls, and withdrawal from the market. For example, the UK stipulates that violating REACH may result in fines or even imprisonment for up to 2 years; the Netherlands stipulates that violating REACH can result in a maximum penalty of 670,000 euros or even 6 years imprisonment; France stipulates that violating REACH can result in administrative or criminal penalties; and Germany stipulates that violating REACH can result in fines, and may also result in imprisonment for 1 to 5 years. |
