Chemicals | Monthly bulletin | February 2023

Europe

New update to Candidate List of Substances of Very High Concern (SVHCs)

On 17^th January 2023, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs.

With the addition of 9 new substances, the current list of SVHCs now contains 233 substances.

See below a table indicating the latest substances addition:

Legal obligations for companies using SVHC substances include:

• Suppliers provide customers and consumers with enough information to allow for safe use of products that contain a substance of very high concern (SVHC) above a concentration of 0.1 % (weight by weight).
• Importers and producers of these products must notify the ECHA if their article contains SVHC substances above a concentration of 0.1% weight by weight (w/w) and the substance is present in those products in quantities totalling over 1 tonne per producer or per importer per year. The notifications have to be submitted within six months from the date it that the substance is included in the list.
• Suppliers of substances on the Candidate List, supplied either on their own or in mixtures, have to provide their customers with a safety data sheet.
• Under the Waste Framework Directive (Directive 2008/98/EC on waste- WFD), any supplier of an article containing a substance of very high concern (SVHC) in a concentration above 0.1% weight by weight (w/w) on the EU market is required to submit a SCIP Notification on that article to ECHA, as of 5 January 2021. SCIP is the database holding information on Substances of Concern in articles, as such or in complex objects (products), established under the WFD. The SCIP database complements the existing notification obligations for Candidate List substances in articles subject to REACH regulation and its related communication through the supply chain, according to Articles 7 (2) and 33 respectively.

Click here to access the official List from ECHA’s website.

European assessment framework for chemicals and materials

On 8^th December 2022, the European commission published Commission Recommendation of 8.12.2022, establishing a European assessment framework for ‘safe and sustainable by design’ chemicals and materials.

The European Commission has adopted a recommendation and its annex to promote research and innovation for safer and more sustainable chemicals and materials.

This text encourages innovation to replace hazardous substances in products and processes, for example in materials in contact with foodstuffs, such as plastic packaging or food containers, textiles or technology products, and information and communication products, such as laptops and tablets. It aims to develop new chemicals and materials, to optimize or redesign production processes and the use of substances currently on the market in order to improve their safety and sustainability.

Additional recent updates regarding REACH Regulation

The following table provides a non-exhaustive summary of some recent updates regarding REACH Regulation (EC) No 1907/2006:

Other interesting links about REACH from the ECHA’s website

• Registry of restriction intentions until outcome - ECHA (europa.eu)
• Registry of SVHC intentions until outcome - ECHA (europa.eu)
• Substance evaluation - CoRAP - ECHA (europa.eu)
• Adopted opinions and previous consultations on applications for authorisation - ECHA (europa.eu)
• Applications for authorisation - current consultations - ECHA (europa.eu)
• Current calls for comments and evidence - ECHA (europa.eu)
• Authorisation List - ECHA (europa.eu)
• ECHA's completed activities on restriction
• Submitted restrictions under consideration
• Assessment of regulatory needs list

Other interesting links about CLP from the ECHA’s website

• Registry of CLH intentions until outcome - ECHA (europa.eu)
• Harmonised classification and labelling consultations - ECHA (europa.eu)

European Initiatives related to chemicals, POP and RoHS legislation

Recent initiatives by the European Commission related to chemicals, POP and RoHS legislations include:

Miscellaneous technical publications relating to PFASs

The latest publications in relation to PFASs are summarised in the table below:

US

New York Approves PFAS in Textiles Regulation

The State of New York recently approved Bill A07063A to amend Section 37-0121 of the Environmental Conservation Law to prohibit intentionally added PFAS chemicals in apparel products, effective December 31^st, 2023.

PFAS is defined as a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.

Apparel is defined as clothing items intended for regular wear or formal occasions, including, but not limited to, undergarments, shirts, pants, skirts, dresses, overalls, bodysuits, vests, dancewear, suits, saris, scarves, tops, leggings, leisurewear, formal wear, onesies, bibs, and diapers. Apparel does not include professional uniforms or outerwear intended for extreme conditions.

New York Prohibits PFAS in Carpets and Establishes New Carpet Recycling Program

The State of New York recently approved Bill A09279A to amend Article 27 of the Environmental Conservation Law by adding a new title 33 to require producers to submit a plan for the establishment of a carpet collection program for unused and discarded carpets for the Department of Environmental Conservation’s (DEC) approval by December 31^st, 2023. No later than July 1^st, 2024 or six months after the plan is approved by the DEC, whichever occurs later, producers must implement the carpet collection program utilizing collection sites, and producers may not sell carpets in the state unless the producer is registered with the DEC on and after the date of implementation of the carpet collection program. On or before July 1^st, 2025, and annually thereafter, producers must submit a report to the DEC that includes, for the previous program year, a description of the program. Beginning July 1^st, 2024, retailers may not sell carpets in the state unless the producer of such carpet is participating in a carpet collection program. On or after one year after a plan is approved by the DEC, carpets sold in the state must be accompanied by the following identifying information:

• Name of the producer and contact information; and
• Carpet material, composition, and type of construction.

All carpets sold in the state must be manufactured with the following minimum amounts from post-consumer sources:

• Within 1 year after the plan is approved by the DEC, a minimum of 10% post-consumer content;
• Within 4 years thereafter, a minimum of 20% post-consumer content; and
• 5 years thereafter, a minimum of 30% post-consumer content.

The new bill will also prohibit carpets containing PFAS substances for any purpose, effective December 31^st, 2024.

A carpet is defined as a manufactured article that is (a) used in commercial buildings or single or multifamily residential buildings, (b) affixed or placed on the floor or building walking surface as a decorative or functional building interior or exterior feature, and (c) primarily constructed of a top surface of synthetic or natural face fibers or yarns or tufts attached to a backing system made of synthetic or natural material. A carpet does not include handmade rugs, area rugs, or mats.

PFAS substances are defined as a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.

California Designates Nail Products Containing Toluene as a Priority Product

California’s Department of Toxic Substances Control (DTSC) listed a new Priority Product under the Safer Consumer Products Regulations: nail products containing toluene. The covered products include nail products containing toluene, including nail coatings and nail polish thinners that contain toluene as an added ingredient, contaminant, or residual. Nail coating includes any clear or colored paint, polish, lacquer, enamel, or gel product marketed or sold for application to fingernails or toenails.

By March 2^nd, 2023, domestic and foreign manufacturers of the covered products must submit to the DTSC a Priority Product Notification (PPN), naming all of the manufacturer’s products that contain toluene, either as an intentionally added ingredient or as a contaminant. After submitting the PPN, manufacturers will have the option to submit one of the following by June 30^th, 2023:

• an Alternatives Analysis Threshold Notification;
• a Chemical Removal Intent/Confirmation Notification;
• a Product Removal Intent/Confirmation Notification;
• a Product-Chemical Replacement Intent/Confirmation Notification; or
• a Preliminary Alternatives Analysis Report or other alternate reporting options.

The Alternatives Analysis Threshold (AAT) for toluene in nail products is set at 100 parts per million (ppm). Manufacturers that demonstrate and certify that the concentration of toluene in their priority product does not exceed the ATT of 100 ppm will not be required to submit an Alternative Analysis Report.

For more information on the PPN, please visit the DTSC’s website here. To see the full text of the new Regulation, please click here.

New York Regulates Mercury in Cosmetics and Personal Care Products

The State of New York recently approved Bill S8291A to amend Section 37-0117 of the Environmental Conservation Law to prohibit Mercury in cosmetics and personal care products, effective June 1^st, 2023. Mercury is defined as elemental mercury Hg, mercuric iodide, mercury oxide, mercurous chloride, ethyl mercury, phenyl mercuric salts, ammoniated mercury, amide chloride of mercury, mercury sulfide or cinnabaris, or mercury iodide. 

A cosmetic product is defined as any article (a) intended to be rubbed, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for beautifying, promoting attractiveness, or altering the appearance, and (b) intended for use as a component of any such article.A personal care product is defined as any product intended for cleaning or cleansing any part of the body, such as the skin and hair, and including but not limited to, hair shampoo, hair conditioner, soap, bath gels and other bath products.

US Passes Modernization of Cosmetics Regulations Act

On December 29^th, 2023, President Biden approved the Consolidated Appropriations Act, 2023, which includes the Modernization of Cosmetics Regulations Act (MCRA). The MCRA amends Chapter VI of the Food, Drug, and Cosmetic Act (FDCA) and significantly expands the Food & Drug Administration’s (FDA) authority over cosmetics. Below are some highlights of the MCRA:

• Facility Registration:
  • Existing cosmetic product manufacturing facilities must register with the FDA by December 29^th, 2023. New facilities must register within 60 days of first engaging in manufacturing or by February 27^th, 2024, whichever date is later. Facility registrations must be renewed every two years thereafter.

• Product listing:
  • Responsible persons must submit product listings for currently marketed cosmetic products to the FDA by December 29^th, 2023. For new cosmetic products, product listings must be submitted within 120 days after marketing such product. Updates to product listings must be submitted every year thereafter.
  • Product listings must include:
    • Facility registration number of each facility
    • Name and contact number of the responsible person
    • Product’s name
    • Applicable cosmetic category or categories
    • List of ingredients, including any fragrances, flavors, or colors, with each ingredient identified by name

• Updated labeling Requirements:
  • Domestic address, phone number, or electronic contact information, through with the responsible person can receive adverse event reports
  • Identification of fragrance allergens
  • Updated labeling requirements for cosmetic products intended for professional use

• Mandatory recall and facility suspension authority:
  • FDA granted the authority to request a voluntary recall or issue a mandatory recall if it determines that there is reasonable probability that a product is adulterated or misbranded and the use of or exposure to the product will cause serious adverse health consequences or death
  • FDA granted authority to suspend a facility registration if it determines that there is reasonable probability of causing serious adverse health consequences or death

• Talc-containing cosmetics:
  • Requires FDA to propose regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products by December 29^th, 2023

• PFAS in cosmetics:
  • Requires Secretary of Health and Human Services to assess the use of PFAS substances in cosmetic products, including risks associated with such use

China

China Releases List of New Pollutants for Priority Management

On December 30^th, 2022, the China’s Ministry of Ecology and Environment issued Order No. 28 to release the first official list of new pollutants for priority management, which will become effective on March 1^st, 2023. The list of new pollutants for priority management contains the following 14 types of new pollutants and its environmental risk control measures:

• Perfluorooctane sulfonic acid, its salts and perfluorooctane sulfonyl fluoride (PFOS and it’s salts)
• Perfluorooctanoic acid, its salts and related compounds (PFOA related)
• Decabromodiphenyl ether
• Short-chain chlorinated paraffins
• Hexachlorobutadiene
• Pentachlorophenol and its salts and esters
• Dicofol
• Perfluorohexyl sulfonic acid, its salts and its related compounds (PFHxS Related)
• Declone and its cis and trans isomers
• Dichloromethane
• Trichloromethane
• Nonylphenol
• Antibiotic
• Obsolete class
  • Hexabromocyclododecane
  • Chlordane
  • Mirex
  • Hexachlorobenzene
  • DDT
  • α- hexachlorocyclohexane
  • β- hexachlorocyclohexane
  • Lindane
  • Endosulfan prodrug and its related isomers
  • Polychlorinated biphenyls

Thailand

Thailand Issues New Standard for Food Utensils Coated with Fluropolymer

The Thai Industrial Standards Institute (TISI) has recently released a new and updated industry product standard. Please see Table 1 below:

Table 1:

International

Miscellaneous technical publications relating to food contact materials

The latest publications in relation to food contact materials are summarised in the table below:

Sustainability, environmental and circular economy

Miscellaneous technical publications relating to environmental, plastics, packaging and waste