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On January 12, 2017, the European Chemical Agency (ECHA) added four new Substances of Very High Concern (SVHC) to the REACH Candidate List for Authorization. The new substances added are called:
- 4-Heptylphenol, branched and linear (4-HPbl) [substances with a linear and/or branched alkyl chain with a carbon number of 7 covalently bound predominantly in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof] all potentially impacted materials and products must be identified. Once identified, a compliance profile will need to be created to itemize all data points and required documentation that will be needed for evaluation. Next, data must be mapped to its source (internal, upstream supply chain), collected, validated and integrated with regulatory lists and your customers’ requests for information. (Equivalent level of concern having probable serious effects to the environment, endocrine-disrupting properties for the environment, Article 57 f) Proposed by Austria. No CAS or EC numbers given. Example of uses include manufacturer of polymers; formulation into lubricants.
- Bisphenol A,4,4'-isopropylidenediphenol (Bisphenol A; BPA) (Toxic for reproduction Article 57c, carcinogenic, mutagenic) Proposed by France. CAS 80-05-7 and EC 201-245-8 Example of uses include manufacture of polycarbonate, epoxy resins and chemicals; hardener in epoxy resins.
- Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts (Persistent Bio-accumulative and Toxic) Proposed by Sweden. CAS 3108-42-7; 335-76-2; 3830-45-3 and EC 206-400-3; 221-470-5 Example of uses include lubricant, wetting agent, plasticizer, and corrosion inhibitor.
- P-(1,1-dimethylpropyl)phenol, 4-tert-pentylphenol (PTAP) (Equivalent level of concern having probable serious effects to the environment, endocrine-disrupting properties for the environment, Article 57 f) Proposed by Germany. CAS 80-46-6 and EC 201-280-9 Examples of uses include the manufacture of chemicals and plastic products.
This addition may impact your company if your company produces or is involved with any of the following:
- Manufacturer or downstream user of chemicals
- Manufacturer or downstream user of polymers
- Manufacturer or downstream user of plastic products
- Manufacturer or downstream user of polycarbonate
- Manufacturer or downstream user of epoxy resins and hardeners
- Manufacturer or downstream user of lubricants
- Manufacturer or downstream user of wetting agents
- Manufacturer or downstream user of plasticizers
- Manufacturer or downstream user of corrosion inhibitors
If you fall into these categories, you may need to revisit your compliance obligations. A successful approach to compliance requires data, systems, expertise and an executable process that starts with 3E’s “3 I’s”:
- Identification – Do you currently use these substances on their own, or as part of mixtures or articles?
- Impact Analysis – Complying depends on the use of the substance as it relates to concentration, annual import/export quantities, current registered uses, and exposure exclusions.
- Information Collection and Distribution – Make sure you can provide documentation and information up and down your supply chain. Consumers are entitled to complimentary information within 45 days of their original request, and ECHA must be conditionally notified no later than 6 months after a substance is listed.
If interpreting, managing and executing on these requirements is burdensome, 3E can help. To receive technical information on the recent SVHC additions, explore best practices and discover how 3E can support supply chain material compliance, click here.