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美國加州發布更新版的65法案化學物質安全標準 (再製)

美國加州發布更新版的65法案化學物質安全標準 加州環境健康危害評估辦公室 (The California Office of Environmental Health Hazard Assessment, OEHHA) 已根據加州第65號法案發布受規範的化學物質之安全標準的更新列表。 此更新版的安全標準包含了最新的致癌物質無顯著危害風險標準 (No Significant Risk Levels, NSRLs),以及具生殖毒性化學物質的最大允許劑量標準 (Maximum Allowable Dose Levels, MADLs)。 詳細內容請參考附件: Proposition 65 NSRLs for Carcinogens & MADLs for Chemicals Causing Reproductive Toxicity_英文版。 資料來源:    Chemical Watch (2013-07-12) (PIDC 編譯) 附件檔案:Proposition 65 NSRLs for

ECHA issues call for comments on proposals for harmonized classification and labeling of two substances and testing of 16 substances

On July 7, 2025, the European Chemicals Agency (ECHA) launched a public consultation on two proposals for harmonized classification and labeling (CLH) of substances, with a deadline of September 5, 2025. On the same day, ECHA added 16 new substance testing proposals and requested public comments by August 21. CLH Proposal Substance name EC number CAS number Hazard category open for consultation Consultation start date Feedback deadline (R)-2-Methyl-5-(1-methylvinyl)-2-cyclohexen-1-one l-p-mentha-1(6),8-dien-2-one; (5R)-2-methyl-5-(prop-1-en-2-yl)cyclohex-2-en-1-one; l-carvone 229-352-5 6485-40-1 Explosive flammable liquid Self-reactive substances and mixtures Pyrophoric liquid Self-heating substances Substances which, in contact with water, emit flammable gases Oxidizing liquid Organic peroxides Corrosive to metals Acute oral toxicity Acute dermal toxicity Acute inhalation toxicity Skin corrosion/irritation Severe eye damage/eye irritation Skin sensitization Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity - single exposure Specific target organ toxicity - repeated exposure Inhalation hazard Hazardous to the aquatic environment Hazardous to the ozone layer 07/07/2025 05/09/2025 Spearmint oil; Esse

The 2025 compliance wave is coming. Are your products ready?

In the first half of 2025, regulations across various markets are tightening simultaneously, from the EU's REACH, SVHC, and POPs updates to mainland China's new VOC standards and California's Proposition 65, which adds vinyl acetate as a carcinogen. This is completely reshaping product formulation and supply chain risk management. In this wave of change, compliance is no longer just about filling gaps; it's an opportunity to enhance corporate resilience and brand trust. Are you facing the following challenges? A common trend in the global market is that compliance requirements are no longer limited to product shipments, but are now extending to every level, including material selection, process control, information disclosure, and declaration responsibilities. Early planning and a comprehensive inventory will not only mitigate regulatory risks but also help enhance brand resilience and market trust. Summary of regulatory updates in the first half of 2025 (from Europe, America to Asia): EU regulatory updates California Proposition 65 updates Mainland China strengthens VOC controls Regulations in other regions: Japan Chemical Evaluation Law updates Canada updates multiple regulations Thailand actively responds to the Stockholm Convention Malaysia strengthens controls on POPs-related chemicals We have compiled the following table for links to relevant interpretations and regulatory documents to help you grasp the key changes more quickly Region Regulations Article European Union EU POPs The EU strengthens its control, and the concentration limit of Dextran will be lowered to 1 mg/kg EU PO

EU releases enforcement report on hazardous substances in consumer products

On December 13, 2023, the European Chemicals Agency (ECHA) released the tenth enforcement report of the REACH Enforcement Forum. This enforcement focused on consumer products and inspected their compliance with the Restriction of Hazardous Substances (RHS) regulations, the POPs Regulation, the RoHS Directive, and the Toys Directive, as well as the information transmission of SVHC in articles. A total of 2,407 products in 26 countries were inspected. The overall non-compliance rate of the 2,407 products inspected in this enforcement inspection was 18%, the non-compliance rate of article-type products was 20%, and the non-compliance rate of mixture-type products was 9%. Inspection data showed that the content of harmful chemicals such as lead, phthalates, and short-chain chlorinated paraffins in products sold to consumers was too high. Compliance with the Restriction of Hazardous Substances In the enforcement inspection of compliance with the Restriction of Hazardous Substances, it was found that the RoHS Directive had the highest non-compliance rate, with 49% of the 329 inspected products not meeting the requirements. The second highest non-compliance rate was the Restriction of Hazardous Substances section (Appendix 1).

EU REACH Annex XVII Formaldehyde Rapid Screening Service

Formaldehyde is an organic compound with a wide range of applications. Common uses include pharmaceuticals, synthetic fibers, plastic preservatives, and reducing agents. It is also used in the preparation of phenolic, urea-formaldehyde, melamine, and polyoxymethylene resins. EU REACH regulations added item 77, formaldehyde, to Annex XVII of the List of Hazardous Substances in July 2023, and will regulate furniture, finished wood products, and other non-furniture and finished wood products in the near future. Formaldehyde's Widespread Uses and Sources: Formaldehyde is a high-volume chemical with a wide range of uses. According to the European Commission, 98% of formaldehyde produced or imported into the EU is used as a reaction intermediate in the production of formaldehyde-based resins, thermoplastics, and other chemicals. These are then used in other industrial applications, such as leather goods, textiles, adhesives, plywood, paints, electrical and electronic products, and polyurethane coatings. The release and impact of formaldehyde in products These products made from formaldehyde derivatives may contain residual formaldehyde that has not been fully reacted or substances that can be degraded into formaldehyde. As a result, during the use of the product, formaldehyde will gradually be released from the product into the surrounding environment in a concentrated diffusion manner, making formaldehyde permeate people's living environment. The potential risks of formaldehyde to human health However, formaldehyde is an organic compound that is irritating to the human eyes, nose, and skin. It has been classified as carcinogenic and irritating by the EU CLP Regulation ((EC) No 1272/2008).

ECHA announces 6 SVHC review substances

On September 1, 2023, the European Chemicals Agency (ECHA) announced a public comment period on six potential substances of very high concern (SVHCs). Among these substances, dibutyl phthalate (DBP), which was added to the official list of SVHCs in October 2008, is being reviewed again to identify new hazards. The public comment period will close on October 16, 2023, during which time stakeholders can submit comments to ECHA. If approved, these five substances, excluding DBP, will be added to the official list of SVHCs, becoming the 30th batch of SVHCs. Substance Information Substance name, CAS number and reason for proposal Chemical structure Common uses 2,4,6-tri-tert-butylphenol2,4,6-tri-tert-butylphenol (2,4,6-TTBP) CAS number: 732-26-3 Reproductive toxicity (Article 57(c)); Persistent, bioaccumulative and toxic (PBT) (Article 57(d)); Very persistent and very bioaccumulative (vPvB) (Article 57(e)) Used as an intermediate/reactant in processing, in the formulation of fuels and fuel additives, and in the formulation of products for the maintenance or repair of motor vehicles and machinery, including lubricants and lubricants. 2-(2H-benzotriazol-2-yl

EU REACH Banned and Restricted Substances Update – Annex 17 will regulate formaldehyde content in products

Formaldehyde is a highly reactive gas at ambient temperature and pressure. It is classified as carcinogenic, mutagenic, skin sensitizing, skin corrosive, and acutely toxic under the EU CLP Regulation (EC) No 1272/2008. An ECHA assessment report released on March 11, 2019, revealed that formaldehyde released from consumer products in indoor environments has serious negative impacts on human health. Formaldehyde is a highly produced, widely used chemical. According to the European Commission, 98% of formaldehyde produced or imported into the EU is used as a reaction intermediate in the production of formaldehyde-based resins, thermoplastics, and other chemicals. These materials, or their extended industrial applications, may release formaldehyde into the environment during use. Formaldehyde is classified as carcinogenic, mutagenic, skin sensitizing, skin corrosive, and acutely toxic under Directive 1998/2008 of the European Parliament and of the Council. Exposure to certain concentrations of formaldehyde can be harmful to humans. The WTO Official Journal (G/TBT/N/EU/888) of May 2, 2022, revealed that the European Commission had notified the WTO of a draft amendment to REACH Annex 17, proposing to limit the formaldehyde emission concentration of finished products placed on the market, prohibiting them from being placed on the market if the concentration exceeds the limit. After nearly a year of deliberation, this draft regulation will officially come into effect.

EU announces new RoHS Annex IV Item 49 exclusion clause

The EU announced the addition of a new exclusion clause for mercury in Annex IV medical devices and monitoring instruments. On July 11, 2023, the EU Official Journal officially published Commission Delegated Directive (EU) 2023/1437, adding the 49th exclusion clause to 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 January 31, 2024, and officially implement them on February 1, 2024. The new contents are as follows: Exemption items Scope of application and date 49 Mercury in melt pressure sensors of capillary rheometers with temperatures exceeding 300°C and pressures exceeding 1000 bar. Expiration date: December 31, 2025 Category 9 applies Source: (EU) 2023/1437 (please refer to the original text for details)

EU REACH SVHC Candidate List Update

  2023/06/16 The European Chemicals Agency (ECHA) announced the latest recommended list of substances of very high concern (SVHC) on February 17, 2023, and opened it for public comments for 45 days. The final approval result was finally announced on June 14, 2023... The European Chemicals Agency (ECHA) announced on its official website on June 14, 2023 that 2 new substances were included in the 29th batch of substances of very high concern (SVHC) candidate list. Currently, there are 235 items in the SVHC candidate list. The newly added items are the same as the 29th batch of substances of very high concern recommended list announced by ECHA in February 2023. These substances were included in the SVHC candidate list because of their persistence, bioaccumulative toxicity and reproductive toxicity. For details of the newly added SVHC candidate list items, please refer to the table below: No. Materials EC No. CAS No. Reason for inclusion Possible applications 1 4,4'-Dichlorodiphenyl sulfone (bis(4-chlorophenyl) sulphone) 201-247-9 80-07-9 vPvB(Article 57e) Used in the manufacture of chemicals, plastic materials and rubber materials. 2 (2,4,6-Trimethylbenzoyl)diphenylphosphine oxide

Latest 2023 EU Audit Actions – Perfluorinated Carboxylic Acids (PFCAs) and Related Substances

On March 23, 2023, the European Chemicals Agency (ECHA) announced its latest enforcement actions for the year on its official website. ECHA's Enforcement Forum agreed to conduct an audit program to assess the conformity of perfluorocarboxylic acids (PFCAs) and related substances under the EU REACH and EU POPs regulations, covering all consumer products. The audits will begin between 2023 and 2024. The audit program will be jointly conducted by the ECHA Enforcement Forum and 12 EU Member States. Any violations identified will result in immediate enforcement action to ensure compliance with the EU REACH and EU POPs regulations. A report on the audit results is expected to be published by the end of 2024. In order to help suppliers cope with the latest EU audit actions, SGS recommends that you immediately evaluate whether your products comply with EU regulations. At the same time, SGS also sorted out the EU REACH and EU POPs regulations on perfluorocarboxylic acid substances (perfluorocarboxylic acid

The latest EU REACH SVHC recommendation list for 2023

The European Chemicals Agency (ECHA) announced the latest recommended list of substances of very high concern (SVHC) on February 17, 2023. The SVHC recommended list includes two chemical substances: 4,4′-dichlorodiphenylsulfone (CAS No. 80-07-9) and (2,4,6-trimethylbenzoyl) diphenylphosphine oxide (CAS No. 75980-60-8). Because these substances are very persistent, very bioaccumulative and reproductively toxic, they have been proposed by the governments of Austria and Sweden to be included in the SVHC candidate list. The public consultation on this proposal will end on April 3, 2023. For relevant information, please refer to the table below: No. Materials EC No. CAS No. Reason for inclusion Possible application 1 4,4'-Dichlorodiphenylsulfone (bis(4-chlorophenyl) sulphone) 201-247-9 8

EU Announcement – ​​New RoHS Annex III Item 9(a)-III Exclusion Clause

The study evaluating RoHS exemption applications concluded that replacing hexavalent chromium in refrigerant solutions is currently scientifically and technically unfeasible, while other heating technologies that eliminate hexavalent chromium in the form of sodium chromate do not offer equivalent functionality and performance. However, gas absorption heat pumps do offer higher energy efficiency and reduced carbon emissions than condensing boilers, meeting the exemption requirements of Article 5 of the EU RoHS Directive 2011/65/EU. Therefore, new exemptions for hexavalent chromium, Sections 9(a)-III, have been added to Annex III of the directive. On January 26, 2023, the Official Journal of the European Union officially published Commission Delegated Directive (EU) 2023/171, adding new exclusions to Sections 9(a)-III of Annex III to the RoHS Directive (2011/65/EU). This update will take effect 20 days after publication. EU member states are required to adjust the relevant legislation and publish it by August 31, 2023, with implementation commencing on September 1, 2023. The new content is as follows: Exemption Scope and date 9(a)-III Hexavalent chromium as a corrosion inhibitor in the working fluid of carbon steel sealing circuits of gas absorption heat pumps for space and water heating, with a weight not exceeding 0.7% of the cooling solution Applicable to Category 1 Expiration date is December 31, 2026 Source: (EU) 2023/171 (For details, please refer to the original text)

EU REACH 28th Substances of Very High Concern (SVHC) Candidate List Update

On January 17, 2023, the European Chemicals Agency (ECHA) announced on its official website that 9 new substances were included in the 28th batch of Substances of Very High Concern (SVHC) candidate list. Currently, there are 233 items in the SVHC candidate list. The newly added items are the same as the 28th batch of recommended list of substances of very high concern announced by ECHA in September 2022, totaling 9 items. These substances were included in the SVHC candidate list because of their persistence, bioaccumulative toxicity, carcinogenicity, reproductive toxicity, endocrine disruption and other characteristics. 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 Possible applications 1 1,2-Bis(2,4,6-tribromophenoxy)ethane 1,1′-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene] 253-692-3 37853-59-1 Very persistent and very bioaccumulative (REACH Article 57 e) Flame retardant additive. 2 Tetrabromobisphenol A 2,2′,6,6′-tetrabromo-4,4′-isoprop

Annex 17 EU Audit Focus for the Next Three Years – REACH Enforcement from 2023 to 2025 Will Focus on Imported Products

The ECHA Enforcement Forum has decided that the focus of REACH enforcement from 2023 to 2025 will be on imported products. The ECHA Enforcement Forum, composed of one representative from each of the EU member states, Norway, Iceland, and Liechtenstein, is responsible for enforcing REACH, CLP, PIC, POPs, and Biocidal Product regulations. The news of the latest ECHA announcement revealed that the ECHA Enforcement Forum decided... In previous enforcement actions, the ECHA Enforcement Forum worked with customs authorities of various countries (16 member states) on a pilot project to conduct compliance audits of REACH and CLP regulations on products that will be imported into the EU market. The audit content covers: Products Planned audit content Planned audit scope Finished products (Articles) Audit the presence of restricted substances in REACH Annex 17 in finished products Main target: Commercial imports (B2B) Target but not priority: Private

EU announces new RoHS Annex IV exclusion clauses 27 and 48

The Official Journal of the European Union officially published Commission Delegated Directives (EU) 2022/1631 and (EU) 2022/1632 on September 22, 2022, adding and revising the exclusion clauses in Annex IV to the RoHS Directive (2011/65/EU), primarily exempting lead in some medical devices. On September 22, 2022, the Official Journal of the European Union officially published Commission Delegated Directives (EU) 2022/1631 and (EU) 2022/1632, adding Annex IV 27 (c) and (d) and 48 exclusion clauses to the RoHS Directive (2011/65/EU). These updates will take effect 20 days after the announcement. EU member states should adjust the relevant laws and publish them by February 28, 2023, and they will officially come into effect on March 1, 2023. The modifications are as follows: Exemption Items Scope of Application and Date 27 (c) Magnetic Resonance Imaging (MRI) equipment with non-integrated receiving coils for which the declaration of conformity for this model is first issued before September 23, 2022, or (d) Magnetic Resonance Imaging (MRI) equipment with integrated receiving coils, the magnets used in the equipment can produce a distance of 1 m from the isocenter 

SASO RoHS Regulation Update!

SASO RoHS has been updated! It mainly amends some of the requirements for obtaining the SASO certificate of conformity for products exported to the region. Come and have a look! The Saudi Standards, Metrology and Quality Organization (SASO) updated the technical regulations on the restriction of hazardous substances in electrical and electronic equipment in August 2022, mainly amending some of the requirements for obtaining the SASO certificate of conformity for products exported to the region. The main changes to SASO RoHS are as follows: SGS Full Service Verification Service & Process: Importers register on the Saber official website → Submit application-related documents → Certification unit reviews → Certificate issuance RoHS document requirements: Applicant Manufacturer or its legal representative Other importers Declaration of Conformity (SDoC) V V RoHS test report X V Risk assessment document X V Product manual V V ISO 9001:2015 certificate (factory) V V Reference source: SASO RoHS TR-Restriction-of-hazardous-Substance-in-Electrical-and-Elec

European Chemicals Agency (ECHA) announces the latest REACH SVHC list of 9 items in the 28th batch

The European Chemicals Agency (ECHA) announced its updated proposed list of Substances of Very High Concern (SVHC) on September 2, 2022. The proposed list includes nine substances, which are recommended for inclusion due to their endocrine disrupting properties, reproductive toxicity, persistence, and bioaccumulation. Public comment on this proposal will run until October 17, 2022. No. Materials EC No. CAS No. Comment Deadline 1 1,2-Bis (2,4,6-tribromophenoxy) ethane 1,1′-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene] 253-692-3 37853-59-1 17/10/2022 2 Tetrabromobisphenol A 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol 201-236-9 79-94-7 17/10/2022 3

EU REACH-Annex 17 Entry 63 proposes to add new regulations on lead and its compounds in PVC

Lead (Pb) is a toxic substance that can affect the development of the nervous system, cause chronic kidney disease, or have an adverse effect on blood pressure. However, lead also has many uses in industrial applications. For example, lead-containing stabilizers can improve the thermal stability of polyvinyl chloride (PVC) during compounding and product production and extend the service life of the product. In the latest draft amendment to Annex 17... Draft content and purpose On June 8, 2022, the World Trade Organization (WTO) issued a notification case. This notification case is a draft amendment to the latest regulation notified by the European Commission (EU). The draft regulation is expected to amend the 63rd item of Annex 17 of EU REACH (Regulation (EC) No 1907/2006), and proposes to add a ban on the placement of PVC products with a lead or lead compound content equal to or greater than 0.1% on the EU market, thereby reducing people's exposure to lead, a toxic metal, and protecting human health and safety. This draft regulation is open to public comment for 60 days and is expected to be finalized in the next 24 hours.

【Important Information】REACH Annex XVII proposes to add new limits on formaldehyde concentrations in vehicle interiors

In May 2022, the European Commission published a draft announcement to add new limits on formaldehyde emissions from vehicle interiors to Annex XVII of REACH Regulation (EC) No 1907/2006. The draft announcement will be subject to a 60-day public comment period, which will close on July 1, 2022, and is scheduled to take effect 20 days after publication in the Official Journal of the European Union. Forty-eight months after the new regulations come into effect, road vehicles intentionally containing formaldehyde or formaldehyde-releasing substances during production will not be allowed to be placed on the EU market if their interior formaldehyde concentration exceeds 0.062 mg/m³, as measured by ISO 12219-1 or ISO 12219-10. Exclusionary items (not applicable): Formaldehyde emission requirements for vehicle parts exported/sold solely to the EU market (36 months after the new regulations come into effect): Effects of formaldehyde on the human body:

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