Weekly Compliance Digest – EU REACH SVHCs & EPA Nanomaterials
EU REACH Candidate List of Substances of Very High Concern for Authorisation
What is it?
Last week, the European Chemicals Agency (ECHA) announced the addition of four new Substances of Very High Concern (SVHCs) to the REACH Candidate List. The Candidate List includes substances that may have serious effects on human health or the environment. ECHA publishes the list to inform the public and industry that these substances are candidates for possible inclusion in the Authorisation List. Once a chemical substance is on the Authorisation List, a company needs to apply for permission to continue using the substance after the sunset date.
Who is affected?
The inclusion of the four new SVHCs to the REACH Candidate List potentially affects suppliers, importers or producers of any of the following four substances, on their own, in mixtures, or in articles:
- 4,4’-isopropylidenediphenol (bisphenol A; BPA) – CAS number 80-05-7
- Examples of uses: Manufacture of polycarbonate, epoxy resins and chemicals; hardener in epoxy resins
- Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts – CAS numbers 335-76-2, 3830-45-3, and 3108-42-7
- Examples of uses: Lubricant, wetting agent, plasticiser and corrosion inhibitor
- p-(1,1-dimethylpropyl)phenol – CAS number 80-46-6
- Example of use: Manufacture of chemicals and plastic products
- 4-heptylphenol, branched and linear
- Examples of use: Manufacture of polymers; formulation into lubricants
What are the requirements?
If the substance is on its own:
- EU and EEA suppliers of the substance must provide their customers with a safety data sheet (SDS).
If the substance is in mixtures:
- EU and EEA suppliers of mixtures may have to provide the recipients, at their request, with an SDS if the mixture contains at least one substance on the Candidate List and the concentration of the substance in the mixture is ≥ 0.1% (w/w).
If the substance is in articles:
- Manufacturers and importers of articles that contain a substance on the Candidate List in a concentration above 0.1% (w/w) must provide sufficient information to allow safe use of the article to their customers or upon request, to a consumer within 45 days of the receipt of the request.
- Manufacturers and importers of articles must notify ECHA if their articles contains a substance on the Candidate List, and if both of the following conditions are met:
- The substance is present in articles in quantities totaling over one ton per producer or importer per year.
- The substance is present in those articles above a concentration of 0.1% (w/w).
The requirements above are just brief summaries. To ensure compliance, be sure to consult ECHA’s webpage on obligations resulting from inclusion in the Candidate List of SVHCs for authorisation, as well as the webpage on Candidate List substances in articles.
Also, REACH applies to products sold in the EU and EEA, but companies from anywhere in the world may be affected by REACH compliance obligations if they export into the EU or EEA, or if they are members of supply chains with downstream members in the EU or EEA.
What is next?
Most of the obligations take effect as of the date of inclusion of the four SVHCs on the Candidate List, i.e. January 12, 2017. However, manufacturers and importers of articles that have an obligation to notify ECHA have six months from the date of inclusion to do so, i.e. before July 12, 2017.
With the addition of the four new substances, the Candidate List of SVHCs for Authorisation now includes 173 substances.
Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements
What is it?
Last week, the EPA published a final rule establishing reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at nanoscale. The agency is requiring entities that manufacture, import or process, or intend to manufacture, import or process these chemical substances to electronically report to EPA certain information.
Chemical substances that have structures with dimensions at the nanoscale (approximately 1-100 nanometers (nm)) are referred to as nanoscale materials or nanoscale substances. A human hair is approximately 80,000-100,000 nanometers wide. These chemical substances may have properties different than the same chemical substances with structures at a larger scale, such as greater strength, lighter weight, and greater chemical reactivity. These enhanced or different properties give nanoscale materials a range of potentially beneficial applications, but the same properties may cause some of these substances to behave differently than conventional chemicals under specific conditions.
Who is affected?
Entities may be potentially affected if they manufacture, import or process, or intend to manufacture, import or process nanoscale forms (forms with particle sizes of 1-100 nm) of certain chemical substances as defined in section 3 of TSCA. However, the rule does not apply in instances where the chemical substances are manufactured, imported or processed as part of articles, as impurities, or in small quantities solely for research and development.
The following industries may be potentially affected by the rule:
- Chemical Manufacturing or Processing (NAICS codes 325)
- Synthetic Dye and Pigment Manufacturing (NAICS code 325130)
- Other Basic Inorganic Chemical Manufacturing (NAICS code 325180)
- Rolled Steel Shape Manufacturing (NAICS code 331221)
- Semiconductor and Related Device Manufacturing (NAICS code 334413)
- Carbon and Graphite Product Manufacturing (NAICS code 335991)
- Home Furnishing Merchant Wholesalers (NAICS code 423220)
- Roofing, Sliding, and Insulation Material Merchant Wholesalers (NAICS code 423330)
- Metal Service Centers and Other Metal Merchant Wholesalers (NAICS code 423510)
What are the requirements?
The final rule requires one-time reporting and recordkeeping of existing exposure and health and safety information on nanoscale chemical substances in commerce, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials 135 days before those new forms are manufactured, imported or processed. The information that needs to be reported to EPA includes:
- Specific chemical identity
- Production volume
- Methods of manufacture and processing
- Use, exposure and release information
- Available health and safety impact data
EPA will use the information gathered to determine if any further action under TSCA, including additional information collection, is needed.
What is next?
The final rule was published in the Federal Register on January 12, 2017, and will be effective on May 12, 2017. Entities that manufacture, import or process a reportable chemical substance during the three years prior to the final effective date of the rule must report to EPA within a year of the rule’s publication.
UPDATE: On May 12, 2017, the EPA announced that the effective date of the final rule would be delayed, from May 12, 2017 to August 14, 2017.
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