Following the implementation of the three major environmental directives—WEEE, RoHS, and EUP—in the EU, a more impactful and far-reaching "green compliance test" is set to take effect. The Registration, Evaluation, Authorization and Restriction of Chemicals (hereinafter referred to as the REACH Regulation) will be enforced in the EU on June 1, 2007. By then, over 10,000 types of chemical products, as well as downstream products that involve the use of chemicals and are intended for export to the EU, will have no alternative but to comply with the regulation.
It is reported that the EU regulation will gradually replace more than 40 existing directives and regulations on chemicals, such as the Directive on the Classification, Packaging and Labelling of Dangerous Substances. According to experts, the REACH Regulation, dubbed the EU’s New Chemicals Legislation, is not a standalone decree or regulation, but an integrated legislative framework covering the production, trade and use of chemicals. It imposes more stringent environmental protection requirements on chemicals exported to the EU, including provisions related to registration, evaluation, authorization and restriction.
Chemicals, raw materials and their products exported by China—such as coatings under EU control, as well as products in sectors including pharmaceuticals, chemical fibers, rubber, plastics, textiles, light industry, electronics, automobiles and home appliances—will be affected. In Guangdong Province alone, nearly 10,000 competitive products across over a dozen major categories are likely to face export barriers.
Like the WEEE and RoHS Directives, the REACH Regulation is formulated to safeguard human health and the environment. It places approximately 30,000 chemical products—either manufactured within the EU or exported to the EU market from other countries—as well as downstream products involving the use of chemicals under a registration, evaluation, authorization and supervision regime. This framework regulates the production, use and distribution of all downstream chemical-based products in the EU market. Many of China’s products may fail to meet the regulation’s basic registration requirements due to a lack of relevant data.
- Registration Provisions: They apply to both widely used existing chemical substances and newly developed ones. Any manufacturer or importer producing or importing more than 1 ton of a chemical substance must submit detailed product information to the REACH database before placing the substance on the market.
- Evaluation Provisions: Competent authorities are required to conduct thorough evaluations of all chemical substances with an annual output exceeding 100 tons. In special cases, evaluation may also cover substances produced in smaller quantities based on their registration data.
- Authorization Provisions: They target chemical substances or components that are of high concern, such as those that are carcinogenic, mutagenic or toxic to reproduction (CMR substances). Government authorities will grant specific authorization for the use of such substances for designated purposes only.
- For new substances with an annual output of over 1 ton: Manufacturers or importers must complete registration 12 months after the regulation takes effect before placing the substances on the market.
- For existing substances:
- Substances with an annual output of over 1,000 tons, as well as carcinogenic or mutagenic substances with an annual output of over 1 ton, must complete REACH registration within 3 years of the regulation’s entry into force.
- Substances with an annual output of 100–1,000 tons must complete registration within 6 years.
- Substances with an annual output of 1–100 tons must complete registration within 11 years.
Products that fail to be registered and included in the regulatory compliance system within the specified timeframes will be prohibited from sale in the EU market.
It is understood that the EU is one of the primary export markets for Guangdong Province. At present, Guangdong’s competitive export products—such as pharmaceuticals, electronics, textiles, plastics and chemical fibers—are downstream chemical products that use chemical raw materials or colorants. At least 10,000 competitive products across more than a dozen major categories in Guangdong will be affected by the regulation, with potential disruptions to their export channels.
Experts point out that the implementation of the EU’s new regulation will have a severe impact on enterprises, particularly leading to a significant increase in manufacturers’ costs. Some small and medium-sized enterprises (SMEs) with limited financial capacity will be unable to meet the regulatory requirements and will have to withdraw from the EU market. Therefore, a reshuffle of the domestic and international chemical industries and related sectors is inevitable.
