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The European Commission has added N,N-dimethylformamide to the list of REACH Annex XVII

N,N-dimethylformamide (DMF) is a reproductive and hepatotoxic substance, potentially harmful to human health with long-term exposure. The Italian government first proposed a legislative proposal to the European Chemical Agency (ECHA) on October 5, 2018, to restrict the industrial use of DMF and its placement on the market as a substance or mixture. This proposal aims to reduce the health risks posed by its use as a solvent. Following extensive consultations, the European Commission announced on November 19, 2021, that DMF will be added to Annex XVII of the REACH Regulation as item 76. The restrictions apply to DMF as a substance, as an ingredient in other substances, or in mixtures at concentrations equal to or greater than 0.3%. The restriction will take effect 20 days after its publication in the Official Journal. REACH Annex 17 entry 76 for N, N-dimethylformamide is as follows: Designation of the substance, of the groups of substances

Taiwan RoHS newly added control item - fabric steamer

The Bureau of Standards, Metrology and Inspection (BSMI), Ministry of Economic Affairs, announced on September 23, 2011, that textile steam engines are included in the list of items subject to inspection. From that date, BSMI will begin accepting applications for type approval or verification registration for these listed products. Effective January 1, 2013, textile steam engines will be subject to inspection for both imported and manufactured products in Taiwan. The inspection method will be a dual-track system: batch-by-batch type approval or verification registration. For new applicants, the certificate is valid from January 1, 2013, to December 31, 2015. Applicants who have already obtained a certificate may use it until its expiration date. During this period, they may apply for additional product categories or verification in accordance with the original inspection regulations. However, starting January 1, 2013, applications to BSMI for certificate extensions will require the submission of the aforementioned documents in addition to the required inspection documents. Product Name Inspection Standard Inspection Method Product Classification Number Textile Steamer (limited to rated voltage below 250V) NS 60335-1 (103 edition) and CNS 60335-2-85 (109 edition) CNS 13783-1 (102 edition) or CNS 13783-1 (102 edition) or CNS 13803 (1992 edition) or CNS 13803 (107 edition) CNS 15663 Section 5 "Contains Marking" (102 edition) Contains secondary lithium batteries, the single battery

Updates to the 26th REACH Substances of Very High Concern (SVHC) Recommendation List

The European Chemicals Agency (ECHA) announced the 26th batch of recommended lists of substances of very high concern (SVHC) on September 3, 2021. The public consultation will end on October 18, 2021. The updated SVHC recommended list includes 4 substances, which are recommended to be included in the SVHC candidate list due to their endocrine disrupting properties, reproductive toxicity, persistence and bioaccumulation. The relevant contents of the ECHA announcement of the 26th batch of substances of very high concern (SVHC) proposed list are as follows: No. Substance name EC No. CAS No. Proposed market Reason for proposal 1 (±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC) (±)-1,7,7-Trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one, including any of the individual isomers and/or combinations thereof (4-MBC) – – Denmark Endocrine disrupting properties (Article 57(f)

Attention! SASO RoHS has been announced on July 9, 2021

SASO RoHS is a mandatory regulation and has officially come into effect on July 9, 2021. From January 5, 2022, electronic and electrical products imported into Saudi Arabia must comply with the requirements of the regulations, otherwise they will not be able to clear customs. There are a total of 6 hazardous substances controlled by SASO RoHS: For newly produced electronic and electrical equipment, a 180-day buffer period is given (calculated from the date of the announcement of the regulations), and they must comply with the regulations from January 5, 2022; products entering the market before July 9, 2021, are given a 365-day buffer period, and products that do not meet the regulatory requirements can only be sold until July 9, 2022. Scope of control: Post-market supervision mechanism: Reference: SASO RoHS

REACH Annex XVII entry68 will be updated soon

The European Commission has determined that the use or manufacture of C9-C14 PFCAs, their salts, and any related substances poses unacceptable risks to human health and the environment. The Commission announced in the Official Journal on August 4, 2021, that C9-C14 PFCAs, their salts, and any related substances will replace entry 68 of Annex XVII, restricting their use as substances, in mixtures, and in total concentrations in articles. The regulation will enter into force 20 days after its publication in the Official Journal. REACH Annex XVII entry 68 specifies the following for C9-C14 PFCAs, their salts and any related substances: Designation of the substance, of the groups of substances or of the preparation Conditions of Restriction 68. Linear and branched perfluorocarboxylic acids of the formula CnF2n+1-C(=O)OH, where n = 8, 9, 10, 11, 12 or 13 (C9-C14 PFCAs), including their salts and any combination thereof;

REACH Annex XVII Test Method Guidance

REACH Annex XVII is a list of banned and restricted substances, containing over 70 major categories. These categories target specific products and materials, prohibiting their manufacture, sale, and use in EU imports that fail to meet regulatory limits. Due to the wide variety of products and materials covered by each category, the European Chemicals Agency (ECHA) published the first edition of guidance on recommended test methods in 2013. Since REACH Annex XVII has expanded to 75 categories, ECHA has updated the guidance on recommended test methods, now in Edition 3.0. According to the guidance, this document serves only as a recommendation for test methods. Users should select appropriate testing methods for the sample material being tested. Therefore, test methods not included in this guidance are acceptable. Currently, this guidance covers 73 categories of REACH Annex XVII, but for a few of these categories, the guidance does not provide any recommended test methods. If you have any questions or testing needs regarding Appendix 17 testing, please contact the Connectivity and Products Business Group / Electronic and Electrical Prohibited and Restricted Substances Service. We will provide the best advice for your product. Source: Recommended Test Methods

EU RoHS adds new restrictions on the use of four plasticizers in medical devices and monitoring instruments!

On June 4, 2015, the European Union officially announced the addition of four phthalates to the List of Prohibited and Restricted Substances (Annex II) of the RoHS (recast) Directive (2011/65/EU). This restriction took effect on July 22, 2021, for medical devices and monitoring instruments. Therefore, all products covered by RoHS regulations must comply with the 10 restricted substances. Medical device manufacturers exporting to Europe must also be aware of the EU Medical Device Directive (MDR). If you have medical device needs for export to Europe, SGS can provide comprehensive testing and other related services, helping you navigate these new medical device requirements and streamline your marketing efforts. If you have any questions, please feel free to contact us. The substances and concentration limits currently controlled by the List of Prohibited and Restricted Substances (Annex II) (single homogeneous material) are as follows: Controlled Substance Concentration Limit (ppm) Cadmium 100 Lead 1,000 Hexavalent Chromium VI 1,000 Mercury 1,000 Polybrominated Biphenyls (PBB) 1,000 Polybrominated Diphenyl Ethers (PBDE) 1,000 Di(2-ethylhexyl) Phthalate (DEHP) 1,000 Butylbenzyl Phthalate

UK REACH work plan for the next two years

On June 16, the UK's HSE (Hazardous Substances Control) (HSE) released its UK REACH work plan for the next two years (2021 and 2022), which appears to be marking a turning point regarding the SVHC list for finished products. The UK REACH work plan is only beginning to assess 10 substances. These include two new substances added to EU REACH in January 2021, seven of the eight substances currently on the latest EU REACH recommended list (minus MCCP), and resorcinol, which the EU notified to the WTO on June 1. Resorcinol is expected to be added to the EU REACH SVHC candidate list in the fourth quarter of this year. The work plan also states that SVHC items will be selected from a wider range of sources in the future. Regarding bans and restrictions, the first item related to tattoo inks was proposed in March of this year, and HSE will also consider EU banned and restricted substances in the future. HSE stated that, looking ahead, the evaluation of the EU's ban and restriction proposals may lead to a UK proposal with a different scope but better suited to addressing UK REACH risks. HSE will increasingly identify priority restriction projects for the UK based on wider analysis of UK needs. Link: UK REACH work programme

EU Announcement Extends the Validity Period of RoHS Annex IV Item 42 Exclusion Clause

On June 2, 2021, the Official Journal of the European Union officially published Commission Delegated Directive (EU) 2021/884, extending the deadline for the 42nd exclusion clause of Annex IV of the RoHS Directive (2011/65/EU). This update will take effect on the 20th day after the announcement. EU member states should adjust the relevant laws and regulations and announce them before June 30, 2022, and officially implement them on July 1, 2022. The modifications are as follows: Exemption items Scope of application and date 42 Mercury in electric rotary connectors for intravascular ultrasound imaging systems with high-frequency (>50MHz) operating modes. Expiration date: June 30, 2026. Source: (EU) 2021/884 (Please refer to the original text for details)

ECHA proposes two new persistent organic pollutants

ECHA recently proposed to add two new persistent organic pollutants and publicly solicited opinions from public interest groups. The consultation deadline is July 13, 2021. There are two projects on which ECHA is publicly soliciting opinions: These two compounds are likely to be proposed to the Stockholm Convention in the future and added to the EU POPs regulations. Detailed information about these two compounds is as follows: Substance name EC Number CAS Number Possible application 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol UV absorber UV-328 247-384-8 25973-55-1 As a UV absorber, it is mainly suitable for polyolefins, polystyrene, polyvinyl chloride, polyurethane, polyester and other products. Methoxychlor 200-779-9 72-43-5 Organochlorine pesticide Source: Two new proposed organic pollutants

EU announces new RoHS Annex III Item 45 exclusion clause

On April 20, 2021, the Official Journal of the European Union officially published Commission Delegated Directive (EU) 2021/647, adding a new exclusion clause to Annex III, Item 45, of the RoHS Directive (2011/65/EU), exempting lead and hexavalent chromium compounds from electronic detonators in civilian (professional) explosives. This addition will take effect 20 days after the publication date. EU member states are required to adjust and publish the relevant legislation by October 31, 2021, with implementation commencing on November 1, 2021. The new contents are as follows: Exemption Scope and Expiration Date 45 Lead diazide, lead styphnate, lead dipicramate, orange lead (lead tetroxide), lead dioxide used in the electronic detonators of civil (professional) explosives and barium chromate as long time pyrotechnic delay charges in the electronic detonators of civil (professional) explosives are applicable to Class 11. Expiration date: April 20, 2026

ECHA delays disclosure of SCIP database information

On March 18, ECHA issued a press release stating that, due to technical difficulties, it would take longer to publish the SCIP notifications received from industry on the ECHA website. ECHA pledged to announce the disclosure timeline as soon as possible to ensure transparent disclosure of hazardous substances in these products to consumers and waste handlers. The release also mentioned the addition of several new FAQs to the SCIP FAQ and the fact that the SCIP database had received over 7.5 million notifications from 3,600 companies as of mid-March.

Changes to SVHC report format / New expression of SVHC test result

To whom may concern, First of all, on behalf of SGS C&P / RSTS is thankful for your selecting and using SGS’ service. Since ECHA has announced new SVHC substances every six months for more than ten years, the SVHC candidate list has accumulated to 211 items. Due to the length of the test items, and in order to make the report easier to read, the test data presentation method will be adjusted from April 1, 2021. In the future, only valuable items will be presented in the report, and a complete SVHC candidate list will be provided in the appendix at the end of the report.

The 25th batch of SVHC recommendation list

On March 9, 2021, the European Chemicals Agency (ECDA) announced the 25th batch of proposed SVHCs. This list will be open to public comment for 45 days. The agency will then review these comments and select appropriate items for inclusion on the SVHC Candidate List. Based on past experience, the vast majority of items on the proposed SVHCs are included on the Candidate List. Therefore, manufacturers are advised to proactively check their products for the following substances before exporting to the EU. Furthermore, for finished products containing SVHC Candidate List items at concentrations above 0.1% (w/w), the agency should be aware of the SCIP Article notification process and assist the EU duty holder in completing the i6z dossier submission. Name EC Number CAS Number Possible Applications 1,4-dioxane 204-661-8 123-91-1 Dewaxing of petroleum products, dye dispersants, dispersants for wood stains, solvents for oil-soluble dyes, metal surface treatment agents, etc. 2,2-bis(bromomethyl)propane1,3-diol (BMP) 2,2-bis(bromomethyl)-1,3-propanediol 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TMP)

EU outsourced investigation agency releases RoHS Pack 15 final report

On March 2, 2021, the German Institute for Applied Ecology (Oeko-Institut), the EU RoHS outsourced investigation agency, released the final report of Pack 15. The Pack 15 project consists of two parts. One part is the evaluation of restricted substances, which uses existing evaluation methods to identify and evaluate possible restricted substances, update the substance list, and evaluate some substances that may be restricted in the future; the other part is the evaluation of exclusion projects, confirming and updating the exemption evaluation methodology, and evaluating new exemption applications. The main contents of the Pack 15 final report are summarized as follows: (For the full content, please refer to the original text below) Reference: Study to support the review of the list of restricted substances and to assess a new exemption request under RoHS 2 (Pack 15) – final Report

REACH-SVHC Candidate List Expands to 211 Items

The European Chemicals Agency (ECHA) released the 24th batch of two SVHC recommended list substances on its official website on September 1, 2020. The following two substances were officially included in the SVHC candidate list on January 19, 2021, and the number of items on the SVHC candidate list has increased to 211. Substance name EC No. CAS No. Date of inclusion Reason for inclusion Potential application scope Tetraethylene glycol dimethyl ether Bis(2-(2-methoxyethoxy)ethyl)ether 205-594-7 143-24-8 19/01/2021 Toxic for reproduction (Article 57c) Solvents for adhesives or fluxes, additives in coating production, lubricant-related applications in refrigerants, battery processes, etc. Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs., and any other stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs., and any other

EU RoHS Exclusion Revision Plan-Pack 22

The EU RoHS exclusion revision plan - Pack 22 officially launched a public consultation on December 23, 2020. The consultation period will last for ten weeks and is expected to end on March 3, 2021. The exclusion items discussed in the plan are shown in the table below: Item Exclusions discussed in RoHS Pack 22 6(a) Lead as an alloying element in steel for processing purposes and in galvanized steel, with a content not exceeding 0.35% 6(a)-Ⅰ Lead as an alloying element in steel for processing purposes, with a content not exceeding 0.35% and in batch hot-dip galvanized steel with a lead content not exceeding 0.2% 6(b) Lead as an alloying element in aluminium, with a lead content not exceeding 0.4% 6(b)-Ⅰ When the source is recycled lead-containing aluminium scrap, the lead content may be up to 0.4% 6(b)-Ⅱ Lead is used in aluminium alloys for processing purposes, with a lead content not exceeding 0.4% 6(c) Lead in copper alloys with a lead content not exceeding 4% 7(a) Lead in high melting point solders (e.g. lead in alloys with a lead content >85%) 7(c)-Ⅰ Electrical and electronic components containing glass or ceramic, excluding dielectric ceramic capacitors, such as piezoelectric devices or glass or ceramic matrix composites. 7(c)-Ⅱ Lead in dielectric ceramic capacitors with a rated voltage of AC 125V or DC 250V or higher The exemption remains valid until the European Commission makes a final decision on the exemption assessment. If the exemption application is rejected or the exemption is withdrawn, the exemption shall be valid for 12 months to 18 months from the date of the decision.

Benzene proposed to be included in Philippine chemical regulations, many products may be banned in the future!

The Philippines recently released a draft Chemical Control Order (CCO) regulating benzene. Benzene is widely used in chemical processes such as coatings, solvents, rubber, and dyes, and has far-reaching impacts across many supply chains. This article summarizes the key points of this draft to help you quickly grasp compliance points and prepare for the process. Amidst the global trend of tightening chemical management, the Philippines has released a draft Chemical Control Order (CCO) regulating benzene and is currently soliciting public comment. Upon formal implementation, the regulations will impose stricter regulations on the import, production, distribution, and use of benzene. The CCO draft aims to comprehensively reduce benzene exposure risks. According to the draft, the Philippine government aims to: Include multiple product categories in prohibited or restricted areas. If passed, the following uses of benzene will be prohibited: Companies that still use these products are advised to immediately initiate alternative evaluations and process adjustments. Applicable to: The entire supply chain. This CCO draft covers a wide range of areas, requiring both upstream and downstream manufacturers to apply for registration and licensing: Any legal person or entity importing benzene must apply for import customs clearance through the agency's online permitting and monitoring system (OPMS). Import customs clearance is valid for six months. Without a license, customs clearance and legal sales will not be possible. Registration/Import Necessary Documents List: Master the Application Requirements at Once Those who wish to apply for registration or import must prepare the following documents:

REACH Proposal List for Decabromodiphenyl Ethane Opens for Public Comment on June 27

The European Chemicals Agency has added decabromodiphenyl ethane to the REACH Recommendation List and is open for public comment. It may be included in the SVHC Candidate List in the future. Decabromodiphenyl ethane included in the REACH Recommendation List Decabromodiphenyl ethane was added to the REACH Recommendation List on June 27, 2025, and is open for public comment until August 11, 2025. Because this substance is very persistent and very bioaccumulative, it is proposed to be included in the SVHC Candidate List. Although the substances in the recommended list have not yet been officially regulated, it means that the hazards of this substance have been paid attention to. In the future, if the hazards of this substance are confirmed after evaluation, it may be included in the SVHC Candidate List. No. Material EC No. CAS No. Reason for inclusion Possible applications 1 1,1′-(ethane-1,2-diyl)bis[pentabromobenzene] decabromodiphenylethane 284-366-9 84852-23-9 Very persistent and very bioaccumulative - Article 57(e) Coatings, lubricants, flame retardants, etc.

EU RoHS Directive Annex III adds new exemption clause 46

Release date: 2024-01-22 On January 10, 2024, the European Commission issued Directive (EU) 2024/232, adding Article 46 to Annex III of the EU RoHS Directive on the exemption of cadmium and lead in plastic profiles for electrical and electronic doors and windows containing recycled rigid polyvinyl chloride (PVC). The directive will take effect on the 20th day after its publication. The relevant exemptions are shown in the table below: Clause Content Scope and Validity Period 46˙ Cadmium and lead in plastic profiles containing mixtures produced from polyvinyl chloride waste (hereinafter referred to as "recycled rigid PVC"), used for electrical and electronic doors and windows, the cadmium content in the recycled rigid PVC material shall not exceed 0.1% (by weight) and the lead content shall not exceed 1.5% (by weight). From 28 May 2026, rigid PVC recycled from electrical and electronic windows and doors may only be used to produce new products of the categories mentioned in points 18(a) to (d) of entry 63 of Annex XVII to (EC) No. 1907/2006 (REACH).

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