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EU REACH 27th Substances of Very High Concern (SVHC) Candidate List Update

On March 4, 2022, the European Chemicals Agency (ECHA) announced the latest proposed list of Substances of Very High Concern (SVHC) and opened it for public comment for 45 days. The final results were finally announced on June 10, 2022... On March 4, 2022, ECHA announced the addition of one substance to the 27th batch of SVHC candidate list. On March 4, 2022, the European Chemicals Agency (ECHA) announced on its official website that one new substance was added to the 27th batch of Substances of Very High Concern (SVHC) candidate list. There are currently 224 items on the Candidate List of Substances of Very High Concern. This newly added item is the same as the one in the 27th batch of Substances of Very High Concern proposed list announced by ECHA at the beginning of this year. N-Methylol acrylamide characteristics N-Methylol acrylamide (CAS No. 924-42-5) is included in the SVHC candidate list because of its carcinogenic and mutagenic properties. N-Methylol acrylamide is mainly used as a polymerization monomer and fluoroalkyl acrylate copolymer to manufacture

The EU plans to include medium-chain chlorinated paraffins (MCCPs) and tetrabromobisphenol A (TBBP-A) in the RoHS control list by the end of 2022!

On May 20, 2022, the European Commission published an initiative on its official website regarding substances restricted under the RoHS Directive. The proposal would add tetrabromobisphenol A (TBBP-A) and medium-chain chlorinated paraffins (MCCPs) to the RoHS restricted substances list. The proposed initiative is expected to be adopted in the fourth quarter of 2022. Final control requirements will be determined by the final decision of the European Commission. SGS recommends that companies continue to monitor our newsletters and develop appropriate control strategies in advance. Two new substances recommended for control In March 2021, the EU RoHS assessment body released the final assessment report of RoHS investigation project Pack 15, recommending that medium-chain chlorinated paraffins (MCCPs) and tetrabromobisphenol A (TBBP-A) be added to the control: About medium-chain chlorinated paraffins (MCCPs) and tetrabromobisphenol A (TBBP-A) Medium-chain chlorinated paraffins MCCPs (including linear or branched chlorinated paraffins with carbon chain lengths of C14-C17) Tetrabromobisphenol A (TBBP-A)

The European Commission is assessing the establishment of an audit system to strengthen and coordinate the enforcement of laws in EU member states.

The European Commission is considering establishing a comprehensive audit system covering compliance standards and targeted controls at all levels of the EU REACH Regulation to strengthen and coordinate law enforcement across EU member states. The system will be part of the newly established European Audit Capacity (EAC) and will be part of the EU executive body's planned revision of enforcement regulations... RAPEX 2021 The uneven proportion of notifications among EU member states has led to unfair trade issues among operators in different member states. For many years, there have been differences in the resources available for regulatory enforcement among EU member states, resulting in different policies and efforts in conducting regulatory compliance audits. According to the 2021 RAPEX Annual Report released by the European Commission, the European Commission received a total of 2,142 notifications of non-compliant products in 2021, including: From the 2021 RAPEX Annual Report, it can be found that the non-compliant product cases reported by the above-mentioned five markets alone accounted for 60% of the total number of notifications in 2021. This situation has led to unfair trade issues among operators in member countries, and also caused product violations due to the inability to conduct extensive audits.

The Norwegian government's random inspection of electrical appliances found that many products contained excessive levels of heavy metals and hazardous substances.

The Norwegian government aims to reduce the levels of hazardous substances affecting public health and the environment in various products through regulations governing chemical substances. Annually, it conducts random audits of products on the market for compliance with regulations such as EU RoHS, EU REACH, and EU POPs. This year's audit results show... The Norwegian Environment Agency conducts annual random audits of products sold to consumers and private and public enterprises to prevent the import of products containing regulated substances that are harmful to health and the environment. This audit investigated kitchen utensils and appliances for the presence of regulated substances that are harmful to health and the environment. To identify relevant products and companies, the Norwegian Environment Agency searched customs import lists for products with relevant customs codes and, based on product import data, selected companies from originating and exporting countries outside the EU for audit. A total of 47 products were purchased for inspection, including blenders, electronic thermometers, smart weighing spoons, and paper cake cups. After screening with a handheld XRF gun to check the heavy metal content in the products and understand the material type, the 36 products that were screened were sent to an external laboratory for chemical analysis for the following items: Exceeding the standard items and content and violating regulations. The chemical analysis results showed that 13 of the 36 products 

The European Commission notified the World Trade Organization of the draft REACH Annex 17 regulation on formaldehyde emissions from articles

Formaldehyde is an organic compound that is irritating to the human eyes, nose, and skin. It is classified as a carcinogen, mutagen, skin sensitizer, skin corrosive, and acutely toxic substance by the EU CLP Regulation ((EC) No 1272/2008). In order to reduce public exposure to environments containing formaldehyde, the World Trade Organization (WTO) published an official communiqué on May 2, 2022... Uses of formaldehyde Formaldehyde is a high-volume chemical substance with a wide range of uses. According to statistics from the European Commission, 98% of formaldehyde produced or imported into the EU is used as a reaction intermediate in the production of formaldehyde resins, thermoplastics, and other chemicals. These materials or their extended industrial applications (such as leather products, textiles, adhesives, plywood, paints, and polyurethane coatings, etc.) may release formaldehyde during use, causing harm to the human body. Therefore, on December 20, 2017, the European Commission asked the European Chemicals Agency (ECHA) to assess the risks to human health from formaldehyde and formaldehyde-releasing substances in mixtures and finished products for consumer use. EU Actions to Regulate Formaldehyde On March 11, 2019, ECHA's assessment report revealed that formaldehyde released from consumer products in indoor environments has serious negative impacts on human health.

Perfluorocarboxylic acids (PFCAs), their salts and related compounds

These substances belong to a broad class of per- and polyfluorinated alkyl substances (PFAS). They can be used as surfactants, exhibiting excellent hydrophobic and oleophobic properties, and are used in a variety of industrial applications. However, these substances pose health and environmental risks, leading international market regulators to gradually regulate them. Perfluorocarboxylic acids (PFCAs), their salts, and related compounds are compounds with the general formula CnF(2n+1)-COOH, CnF(2n+1)-COOX', or CnF(2n+1)-X, where X' = any group and X = any group other than F, Cl, and Br. Their chemical structure primarily consists of carbon atoms bonded to fluorine atoms. The strong carbon-fluorine bond contributes to the extreme stability of these substances. This type of substance belongs to a large class of per- and polyfluorinated alkylated substances (PFAS). It can be used as a surfactant and has good hydrophobic and oleophobic properties. It is used in a variety of industrial applications. However, these substances are harmful to humans and the environment. Therefore, the competent authorities of various markets around the world have gradually included them in the regulation.

The European Commission has included five SVHC substances in the REACH Authorisation List

The European Commission has added 5 substances of very high concern (SVHC) to REACH Annex XIV because these substances have reproductive toxicity, carcinogenicity or endocrine disrupting properties. The included substances include... The European Chemicals Agency (ECHA) announced on its official website on October 1, 2019 that ECHA recommended to the European Commission to include 18 SVHC substances in the REACH Authorization List for control; because these substances have reproductive toxicity, endocrine disrupting properties, persistence and bioaccumulation, if the proposal is approved by member states, the European Commission and the European Parliament, these substances will be included in REACH Annex XIV. The REACH Annex XIV amendment issued on April 8, 2022 revealed that the European Commission has decided to first add 5 SVHCs to the authorization list REACH Annex XIV&n

N-Methylolacrylamide added to REACH SVHC proposal list

The European Chemicals Agency (ECHA) announced the latest recommended list of substances of very high concern (SVHC) on March 4, 2022. The items on the SVHC recommended list announced this time are... The European Chemicals Agency (ECHA) announced the latest recommended list of substances of very high concern (SVHC) on March 4, 2022. The updated SVHC recommended list includes one substance, N-(hydroxymethyl)acrylamide (CAS No. 924-42-5). N-(hydroxymethyl)acrylamide is widely used in industrial applications such as fiber modification, resin processing, coatings, adhesives, polymers and polymerization process additives. Due to its carcinogenic and mutagenic properties, the Swedish government proposed to ECHA to include it in the SVHC candidate list. The public consultation on this proposal will end on April 19, 2022. No. Materials EC No. CAS No. Inclusion reason 1 N-(hydroxymethyl)acrylamide 213-103-2 924-42-5 Carcinogenic (Article 57a); Mutagenic (Article 57b)

EU amends Annex III of RoHS Directive to exclude multiple mercury clauses

On February 24, 2022, the European Union published in its Official Journal 12 amendments to the mercury exemptions in Annex III of the RoHS Directive. The relevant directives will take effect 20 days after the announcement, and member states will have six months to transpose them into local laws. The final amendments are as follows: The European Commission has terminated the existing exemptions for the use of mercury in lamps. According to the conclusions of the European Commission's assessment since 2016, safe and mercury-free alternatives can be widely used in fluorescent lamps, and therefore a number of mercury exemptions will be terminated. On February 24, 2022, the European Union published in its Official Journal 12 amendments to the mercury exemptions in Annex III of the RoHS Directive. The relevant directives will take effect 20 days after the announcement, and member states will have six months to transpose them into local laws. The final revision results are summarized as follows: No. Exemption Scope and Duration Updated Directive 1(a)~(e) 1(a): General lighting purposes <30 W: 2.5 mg1(b): General lighting purposes ≥ 30 W and < 50 W: 3.5 mg1(c): General lighting purposes ≥ 50 W and < 150 W: 5 mg1(d): General lighting purposes ≥ 150 W: 15 mg1(e): General lighting purposes, the structure is round or

January 2022 - EU Member States report violations of EU regulations RAPEX case sharing

At the beginning of 2022, EU member states continued to inspect products circulating in the European market. The latest RAPEX notification information announced on the official website of the European Commission revealed the violation cases in January 2022. The violations included... The EU Rapid Alert System for Dangerous Non-Food Products (RAPEX, now known as Safety Gate) will compile the information on non-compliant products reported by member states every week and announce the relevant information on the official website of the European Commission. In the RAPEX cases announced between January 1 and January 28, 2022 (RAPEX Report-2022-1~RAPEX Report-2022-4), a variety of electronic and electrical products violated Annex XVII of the REACH Regulation (Regulation (EU) 1907/2006), the RoHS Directive (Directive 2011/65/EU) and the POPs Regulation (Regulation (EU)

Resorcinol to be added to REACH SVHC Candidate List

Resorcinol (1,3-benzenediol CAS No. 108-46-3) is widely used in the manufacture of tires, rubber products, adhesives and industrial resins. However, it is suspected of interfering with the human thyroid gland. On February 25, 2020, the French government submitted a request to the European Chemicals Agency (ECHA) under Article 59(3) of the REACH Regulation (EU) 1907/2006 to remove resorcinol (1,3-benzenediol CAS No. 108-46-3) was identified as a substance of very high concern. Although most of the Member States Committee members (MSC) at that time agreed that resorcinol had the property of disrupting the thyroid gland and had serious effects on human health, three members still believed that there was insufficient scientific evidence to show that it could have serious effects on human health. As a result, three member states opposed it and eight member states abstained from voting during the approval process. Therefore, it was not approved.

EU outsourced investigation agency publishes final report on RoHS Directive Pack 22 exemptions

On January 13, 2022, the German Institute for Applied Ecology (Oeko-Institut) released its final report on RoHS Pack 22. The report evaluated and recommended extensions for nine exemptions in Annex III: 6(a), 6(a)-I, 6(b), 6(b)-I, 6(b)-II, 6(c), 7(a), 7(c)-I, and 7(c)-II. The final evaluation report for EU RoHS investigation Pack 22 was officially released on January 13, 2022. The report evaluated and made recommendations on the extension of 9 exemption clauses in Appendix III, namely 6(a), 6(a)-I, 6(b), 6(b)-I, 6(b)-II, 6(c), 7(a), 7(c)-I and 7(c)-II, involving a variety of materials widely used in electronic and electrical products, such as steel alloys, aluminum alloys, copper alloys, high-temperature solders, glass and ceramics in electronic and electrical components. In addition, the report added 6(a)-II, 6(b)-III, 6(b)-IV, 7(c)-V, 7(

EU REACH 26h Substances of Very High Concern (SVHC) Candidate List Update

The European Chemicals Agency (ECHA) announced the 26th batch of Substances of Very High Concern (SVHC) candidate list on September 3 last year and opened it for public comment for 45 days. The final results were finally announced on January 17, 2022... The European Chemicals Agency (ECHA) announced on its official website on January 17, 2022 that four new substances were added to the 26th batch of Substances of Very High Concern (SVHC) candidate list. There are currently 223 items on the SVHC candidate list. The newly added items are the same as the 26th batch of SVHC recommended list announced by ECHA last year. These substances were included in the SVHC candidate list because of their endocrine disrupting properties, reproductive toxicity, persistence and bioaccumulation. For detailed information on the newly added SVHC candidate list items, please refer to the table below: No. Materials EC No. CAS No. Reason for inclusion 1 (±)-1,7,7-trimethyl-3-[(4-methylphenyl)meth

SASO RoHS implementation delayed for half a year

The Saudi Arabian Standards Organization (SASO) has postponed the implementation of SASO RoHS by six months from the scheduled January 5, 2022. The implementation date will vary depending on the product category. The Saudi Arabian Standards Organization (SASO) has postponed the implementation of SASO RoHS by six months from the scheduled January 5, 2022. The implementation date will vary depending on the product category. Please refer to the table below for detailed implementation dates: Product Category Implementation Date 1a. Large household appliances October 2, 2022 1b. Small household appliances July 4, 2022 2. Information and communication technology equipment December 31, 2022 3. Lighting equipment March 31, 2023 4. Electrical and electronic tools and equipment June 29, 2023 5. Leisure, entertainment and sports equipment September 27, 2023 6. Monitoring and control equipment December 26, 2023

EU Member States report violations of REACH and POPs regulations through RAPEX: Case studies

The RAPEX Report-2021-51 of December 24, 2021, revealed multiple product violations of Annex XVII of the REACH Regulation (Regulation (EU) 1907/2006) and the POPs Regulation (Regulation (EU) 2019/2021), including electronic and electrical products such as headphones and massagers. The disclosed information includes: product name, violation of regulations, type of hazardous substances and components with excessive concentrations of hazardous substances. The main violations are plastic and rubber components in each product and solder on printed circuit boards. Please refer to the table below for the details of the announced violation cases:

Electronic and electrical products imported into the Kingdom of Saudi Arabia must obtain a product conformity certificate

SASO RoHS has officially come into effect on July 9, 2021. From January 5, 2022, electronic and electrical products imported into Saudi Arabia must not only comply with the requirements of RoHS regulations, but also other mandatory technical regulations in order to obtain a product conformity certificate. Certificate Category: How to determine whether to do Saber verification? Does Saber verification require factory inspection or inspection? Generally, low-risk products do not require factory inspection and inspection, and a product test report is sufficient. Some strictly controlled products, such as ceramics, food contact, free equipment, infant products, etc., require factory inspection. Verification process: Importers register on the Saber official website → Submit application-related documents → Issuing unit reviews → Issue certificate

EU Enforcement Forum agrees to conduct focused inspections on the ban and restriction of dichloromethane and N-methylpyrrolidone

The Enforcement Forum is an institution under the European Chemicals Directorate-General. Its members are composed of one enforcer from each member state. It is responsible for coordinating and enforcing EU regulations. At its meeting in November, it decided on an inspection plan... At the Enforcement Forum meeting in November 2021, the members of the Enforcement Forum agreed to implement a pilot program in the future to control the use and marketing of dichloromethane (DCM) in paint strippers and N-methylpyrrolidone (NMP) used in the workplace. N-methylpyrrolidone is widely used in the production of petrochemicals, electronic components and plastic materials. The plan is expected to be implemented as early as the second half of 2022. In the EU, the relevant regulations for dichloromethane and N-methylpyrrolidone are clearly listed in the REACH regulation. Annex 17 stipulates that the concentration of dichloromethane in paint strippers cannot be greater than or equal to 0.1%, while the regulation for N-methylpyrrolidone is that its concentration cannot be greater than or equal to 0.3% as a single substance or in a mixture. In addition, N-methylpyrrolidone is also listed as

EU RoHS Annex IV adds 3 new plasticizer exclusions

On November 15, 2021, the European Union officially issued Commission Delegated Directive (EU) 2021/1978, (EU) 2021/1979, (EU) 2021/1980, adding exclusion clauses 45, 46, and 47 to Annex IV of the RoHS Directive (2011/65/EU), stipulating the exemption of plasticizers in medical devices. This addition will take effect from the date of the announcement. On November 15, 2021, the European Union officially issued Commission Delegated Directive (EU) 2021/1978, (EU) 2021/1979, (EU) 2021/1980, adding exclusion clauses 45, 46, and 47 to Annex IV of the RoHS Directive, stipulating the exemption of phthalates in medical devices. This addition will take effect from the date of the announcement. EU member states should adjust the relevant laws and regulations and announce them before April 30, 2022, and formally implement them on July 21, 2021. The new contents are as follows: Exemption items Scope of application and expiration date 45 DEHP in ion-selective electrodes used to analyze the presence of ionic substances in human body fluids and/or dialysate. Expiration date: July 21, 2028 46 DEHP in plastic components of magnetic resonance imaging (MRI) detector coils. Expiration date: January 1, 2024 47 DEHP in medical devices (including in vitro diagnostic medical devices and

EU Member States report cases of electronic products violating Annex 17 of the REACH Regulation

EU member states conduct routine inspections on products put on the market to see if they comply with relevant laws and regulations. Cases of non-compliant products will be reported to the European Commission and product-related information such as the country of production, product name, violations, and legal violations will be made public. Recently, the European Commission’s notification system (RAPEX) reported a number of electronic products that violated the regulations in Annex 17 of the REACH Regulation (EU) 1907/2006. The content of the announced violation cases is as follows: Note: The above Chinese translation is for reference only. If there are any errors, please refer to the original announcement. Source of RAPEX violation cases: European Commission SGS reminds you that in addition to routine EU RAPEX audits, the 2022 EU annual audit plan (ECHA/NR/20/24) will focus on auditing the compliance of banned and restricted substances in EU REACH and POPs regulations, as well as the compliance of responsibilities related to substances of very high concern (SVHC) in finished products under REACH regulations (Article 33). SGS recommends that before exporting products to Europe, be sure to pay attention to whether the products comply with the following REACH and POPs regulations: Regulation name Regulatory item Regulatory content Exceeding the limit

EAEU RoHS Regulation TR 037/2016 is about to be revised!

The draft amendment to the EAEU RoHS was published on October 25, 2021, with public discussion scheduled from November 19, 2021, to January 21, 2022. This draft update includes four key areas. SGS will keep you updated with the latest international developments. The Eurasian Economic Union (EAEU, comprising Russia, Belarus, Armenia, Kyrgyzstan, and Kazakhstan) enacted "On the restriction of the use of hazardous substances in electrotechnical and radio-electronic products" on October 18, 2016. The draft amendment to TR 037/2016 was published on October 25, 2021, with public discussion scheduled from November 19, 2021, to January 21, 2022. Main changes:

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