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Latest developments of 6 EU regulations including RoHS and REACH

2021-06-11

    

  The EU RoHS may include MCCPs and TBBPA in the list of restricted substances.

  Recently, Oeko-Institut e.V. released the final report of the "Research on Supporting the Review of the Restricted Substance List and the Evaluation of New Exemption Proposals (Pack 15)" project, recommending that two harmful substances, medium-chain chlorinated paraffins (MCCPs) and tetrabromobisphenol A (TBBPA), be included in the Annex II of the EU RoHS Directive's restricted substance list. The main reason for this recommendation is that these two substances pose significant risks of exposure hazards to workers, consumers, and the environment. The European Commission will make the final decision based on the recommendations in the report. This project was initiated in 2018, and one of its important contents was to assess seven substances that could be included in RoHS 2.0, namely, antimony trioxide, tetrabromobisphenol A, indium phosphide, medium-chain chlorinated paraffins, beryllium and its compounds, nickel sulfate and amino sulfonic acid nickel, cobalt dichloride and cobalt sulfate. The overall project assessment lasted for 18 months. Additionally, in April 2018, the European Commission issued a public consultation for these 7 substances for 8 weeks based on the work content of this project.

  2. The EU RoHS has added an exemption clause for lead and hexavalent chromium in explosive detonators.

  On April 20, 2021, the Official Journal of the European Union (OJ) published the revised authorization directive (2011/65/EU) and the corresponding EU directive (EU) 2021/647. In the EU RoHS Appendix III, a new exemption clause (Article 45) was added, which pertains to the exemption of specific lead and hexavalent chromium compounds in civilian (professional) explosive electronic detonators. This clause will come into effect officially on November 1, 2021.


 

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  3. ECHA proposed that the European Commission add seven substances to the list authorized by the REACH regulation.

  On April 14, 2021, the official website of the European Chemicals Agency (ECHA) released a message proposing that the European Commission add eight substances to the list authorized by the REACH regulation. These substances are octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), dodecamethylcyclohexasiloxane (D6), hydrogenated triphenyl, dihexyl phthalate (DCHP), disodium octa-borate, and trimellitic anhydride (TMA). All of these seven substances were included in the SVHC candidate list as the 19th batch on June 27, 2018. The final decision to include these substances (SVHCs) in the authorized list will be made jointly by the European Commission, EU member states, and the European Parliament. These decisions will also indicate the date by which companies need to apply to the European Chemicals Agency for authorization to continue using these substances.

  4. The EU has proposed including thioquat in the Appendix A of the Stockholm Convention.

  On April 7, 2021, the Official Journal of the European Union published (EU) 2021/592, proposing to add a new chemical substance to the Appendix A of the Stockholm Convention on Persistent Organic Pollutants (the persistent organic pollutants to be phased out): Chlorpyrifos (trade name: Thiodicarb, Termidor, etc.). Previously, the EU (EC) No 1107/2009 regulation and (EU) No 528/2012 regulation did not approve Chlorpyrifos as an active substance and did not allow its release into the EU market for use in plant protection products or biocidal products. Moreover, according to the EU REACH regulation, Chlorpyrifos has not been registered for any other uses, so no manufacturer or importer is allowed to produce or release more than 1 ton of Chlorpyrifos into the EU market for such other uses each year. Although Chlorpyrifos has been gradually phased out in the EU, it still seems to be used as an insecticide and spread in the environment outside the EU. Due to the potential long-range environmental migration characteristics of Chlorpyrifos, measures taken only at the EU level are not sufficient to ensure protection of the environment and human health. Therefore, necessary measures need to be taken on an international scale.

  5. Hainan has issued the supervision and inspection implementation rules for fully biodegradable products

  On March 30, 2021, the Market Supervision and Administration Bureau of Hainan Province issued an announcement regarding the implementation rules for quality supervision inspections of 29 types of products in 2021, including new materials. Among them, the detailed rules related to biodegradation were the "XZ17-2021 Implementation Rules for Quality Supervision Inspections of All-Biodegradable Plastic Products in Hainan Province". Hainan has been building an ecological civilization demonstration island and has always been at the forefront of responding to the plastic ban order. It has also formulated relatively strict local standards, namely "DB46/T 505-2020 General Technical Requirements for All-Biodegradable Plastic Products". Additionally, biodegradable products entering Hainan need to be registered and filed on the official website of the Hainan government. At the end of 2020, a company in Hainan that produced ordinary plastic products falsely claimed to be "100% fully biodegradable" and was severely punished with a fine of 1 million yuan.

  6. ASEAN releases the general guidelines for food contact materials and GMP

  On April 12, 2021, the Food Working Group of the Association of Southeast Asian Nations (ASEAN) released two guidelines on food contact materials online, namely the "ASEAN General Guidelines for Food Contact Materials" and the "ASEAN Good Manufacturing Practice Guidelines for Food Contact Materials GMP". The "ASEAN General Guidelines for Food Contact Materials" describes the scope of application of the guideline documents, relevant terms, introduces the general principles and requirements for food contact materials, measures that may be taken for specific materials in the later stage, requirements for labels and markings, requirements for compliance declarations DOC, requirements for product traceability, and inspection and control measures. Later, ASEAN plans to formulate specific measures and standards for 17 types of materials, including active and intelligent materials, adhesives, ceramics, cork stoppers, etc. The "ASEAN Good Manufacturing Practice Guidelines for Food Contact Materials GMP" defines the terms related to FCM manufacturing, including "Good Manufacturing Practice GMP", "food contact surfaces and non-food contact surfaces", etc., and outlines the quality assurance system. Additionally, the appendix provides examples using plastics and introduces the production hygiene norms for food contact plastic materials and products.