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Media Centre >> News >> Regulatory updates 02-2023

Regulatory updates 02-2023

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Chemical

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:

Nº	Substance name	EC number	CAS number	Reason for inclusion	Examples of use(s)
1	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)	While the substance itself is not registered under REACH, identification as an SVHC can be seen as a measure to avoid future regrettable substitution.
2	2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol	201-236-9	79-94-7	Carcinogenic (Article 57 a)	As a reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxy coated circuit boards, printed circuit boards, paper and textiles.
3	4,4'-sulphonyldiphenol (Bisphenol S)	201-250-5	80-09-1	Toxic for reproduction (Article 57 c); Endocrine disrupting properties (Article 57 f – environment); Endocrine disrupting properties (Article 57 f – human health)	In the manufacture of: pulp, paper and paper products, textile, leather or fur and chemicals.
4	Barium diboron tetraoxide	237-222-4	13701-59-2	Toxic for reproduction (Article 57 c)	In paints and coatings.
5	Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof	-	-	Very persistent and very bioaccumulative (Article 57 e)	As a flame retardant and as a plasticiser for flexible polyvinylchloride and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings and adhesives.
6	Isobutyl 4-hydroxybenzoate	224-208-8	4247-02-3	Endocrine disrupting properties (Article 57 f – human health)	In the manufacture of substances and in the following products: coating products, fillers, putties, plasters, modelling clay and inks and toners.
7	Melamine	203-615-4	108-78-1	Equivalent level of concern having probable serious effects to human health (Article 57 f – human health); Equivalent level of concern having probable serious effects to the environment (Article 57 f – environment)	In polymers and resins, coating products, adhesives and sealants, leather treatment products, laboratory chemicals.
8	Perfluoroheptanoic acid and its salts	-	-	Toxic for reproduction (Article 57 c); Persistent, bioaccumulative and toxic (Article 57 d); Very persistent and very bioaccumulative (Article 57 e); Equivalent level of concern having probable serious effects to human health (Article 57 f – human health); Equivalent level of concern having probable serious effects to the environment (Article 57 f – environment)	While the substance itself is not registered under REACH, identification as an SVHC can be seen as a measure to avoid future regrettable substitution.
9	reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine	473-390-7	-	Very persistent and very bioaccumulative (Article 57 e)	Used in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites and in manufacturing.

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:

Summary of the most recent updates
Date	Subject	Link
29/11/2022	Request to the European Chemicals Agency (ECHA) to support the Commission’s preparation of a restriction proposal for the use and presence of hazardous chemicals in childcare articles based on Article 68(2) of REACH.	More information on ECHA’S website here.
21/12/2022	Germany submitted a proposal to the European Chemicals Agency (ECHA) that would restrict the sale of mixtures and articles containing BPA at a concentration greater than 10 ppm (0.001 % by weight), as well as other bisphenols and bisphenol derivatives (BoSC – BPB, BPS, BPF and BPAF) thought to have endocrine disrupting properties.	More information on ECHA’S website here.
21/12/2022	The European Chemicals Legislation Finder (EUCLEF) has been updated with information on the: Cosmetics Regulation; Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive; Plant Protection Products Regulation; and Pesticides Residues Regulation.	More information on ECHA’S website here.
21/12/2022	Nanopinion: Controlling exposure to nanomaterials.	More information on EUON’S website here.
06/01/2023	Request to the European Chemicals Agency (ECHA) to reassess the concentration limits for eight Polycyclic Aromatic Hydrocarbons (PAHs) in loose rubber granules and mulches used in children’s playgroungds, as well as other domestic applications, and propose restrictions if necessary.	More information on ECHA’S website here.
13/01/2023	ECHA receives PFASs restriction proposal from five national authorities. Denmark, Germany, the Netherlands, Norway and Sweden have submitted a proposal to ECHA to restrict per- and polyfluoroalkyl substances (PFASs) under REACH. The proposal became available on ECHA’s website on 7^th February 2023.	More information on ECHA’S website here.

Other interesting links about REACH from the ECHA’s website

Other interesting links about CLP from the ECHA’s website

European Initiatives related to chemicals, POP and RoHS legislation

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

Initiative	State
Electrical equipment – mercury in melt pressure transducers for specific capillary rheometers (RoHS exemption) This initiative concerns a request for an exemption for mercury in melt pressure transducers for capillary rheometers under extreme conditions used as monitoring and control instruments.	Feedback period closed in January 2023; adoption by Commission is planned for Q1 2023.
Persistent organic pollutants – PFOS limits and exemptions Perfluorooctanesulfonic acid (PFOS) and its derivatives are listed in Annex I to Regulation (EU) 2019/1021. This measure will reduce the maximum PFOS concentration allowed as unintentional trace contaminant in substances, mixtures and articles and will remove the last specific exemption allowed in the EU since it is no longer needed.	The European Commission is preparing the draft act.
Revision of EU legislation on hazard classification, labelling and packaging of chemicals For the implementation of the Green Deal, the chemicals strategy for sustainability sets out a number of actions that require a targeted revision of the Regulation on the classification, labelling and packaging of chemical substances and mixtures. Various options for revision will be analysed in an impact assessment and, based on the results, the Commission will present legislative proposals for a revision of both the enacting terms of and the annexes to that Regulation.	The feedback period concerning adoption by the Commission is opened until 29^th March 2023.

Miscellaneous technical publications relating to PFASs

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

Date	Country/ Region	Entity	Publication
13/01/2023	BfR (German Federal Institute for Risk Assessment)	Germany	Per- and polyfluoroalkyl substances (PFASs): Proposal for restriction under the REACH Regulation submitted to the European Chemicals Agency.
13/01/2023	The Environmental Protection Agency	Denmark	Proposal for limiting PFAS submitted to the EU.
13/01/2023	Federal Institute for Occupational Safety and Health (BAUA)	Germany	Restriction proposal for PFAS submitted to the European Chemicals Agency.
13/01/2023	National Institute for Public health and the Environment	Netherlands	Proposed European PFAS ban officially submitted.
13/01/2023	Norwegian Environment Agency	Norway	Proposals to ban PFAS have been submitted to ECHA. The Norwegian Environment Agency and the authorities in four other countries have submitted a proposal to the European Chemicals Agency to ban fluorinated substances (PFAS).
13/01/2023	Swedish Chemicals Agency	Sweden	Sweden behind a bill to stop the use of PFAS within the EU. Together with authorities in four other countries, the Chemicals Inspectorate has submitted a comprehensive proposal to the EU to limit the use of roughly 10,000 PFAS chemicals.
17/01/2023	Ministry of Ecological Transition and Territorial Cohesion	France	The 2023-2027 "PFAS" action plan. The aim is to strengthen the protection of French people and the environment against the risks associated with PFAS. This plan is based on following six areas of action: Stablishing standards to guide public action; Introducing a broad ban at European level to eliminate the risks associated with the use or the placing on the market of PFAS; Improving knowledge of discharges, as well as the impregnation of environments to reduce the exposure of populations; Significantly reducing industrial emissions; Ensuring complete transparency on the information available; Integrating actions on PFAS into the micropollutants plan.

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:

Category	Standard	Effective Date
Food Contact Materials	TIS 2622-2556 Fluropolymer-Coated Utensils for Food	April 2^nd, 2023

International

Miscellaneous technical publications relating to food contact materials

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

Date

Entity

Publication

17/11/2022

MERCOSUR

Publication of MERCOSUR/GMC/ Res. No 26/22 which modifies the Resolution no. 40/15 “MERCOSUR technical regulation on cellulosic materials, packaging and equipment intended to be in contact with food”.

MERCOSUR Members (Argentina, Brazil, Paraguay and Uruguay) have to transpose the amendment into their national law by May 16, 2023.

05/01/2023

Brazilian Health Regulatory Agency (ANVISA)

Draft resolution number 1134, 23 December 2022.

This Draft Resolution proposes the modification of the current regulatory framework regarding the technical regulation on provisions for packaging, coatings, utensils, lids and metallic equipment in contact with food. (G/TBT/N/BRA/1464).

Sustainability, environmental and circular economy

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

Date	Country/ Region	Publication
16/12/2022	Belgium	An international instrument to reduce plastic pollution. From November 26 to December 2, the 1^st meeting of the Intergovernmental Negotiating Committee on Plastic Pollution (INC1) took place in Punta del Este, Uruguay. This is the 1^st session of a series of 5 whose objective is to set a new legally binding international instrument to fight against plastic pollution, including in the seas and oceans. The final result of these negotiations is expected by the end of 2024. It should have an impact comparable to that of the Paris Climate Agreements.
16/12/2022	France	Order of December 8, 2022 establishing the national plan for reducing emissions of atmospheric pollutants. The PREPA defines the actions to be implemented to achieve the national objectives for reducing emissions of certain atmospheric pollutants (SO2, NOx, VOCNM, NH3, PM2.5) for the years 2025 and 2030 defined in article D. 222- 38 of the environment code pursuant to article L. 222-9 of the environment code.
22/12/2022	Europe	Commission Delegated Regulation (EU) 2022/2526 of 23 September 2022 amending Regulation (EU) 2017/852 of the European Parliament and of the Council as regards the temporary storage of mercury waste in liquid form (C/2022/6696) was published.
31/01/2023	Europe	New product priorities for Ecodesign for Sustainable Products. European Commission opened the public consultation which the Commission seeks views on the categories of new products that is subject to performance and information-related requirements, to ensure greater sustainability.
14/01/2023	UK	The UK Environment Secretary announced that a range of polluting single-use plastics will be banned in England in October 2023. The ban will include single-use plastic plates, trays, bowls, cutlery, balloon sticks, and certain types of polystyrene cups and food containers. For more information here.
14/01/2023	UK	Publication of the Summary of responses and government response related to a call evidence on single-use plastic items which are commonly littered. They were interested in views on following single-use plastic items: wet wipes, tobacco filters, sachets, single-use cups. They were also asking for views on how to shift away from single-use items to reusable or refillable alternatives.
17/01/2023	UK	The Packaging Waste (Data Reporting) (Scotland) Regulations 2023 (Scottish S.I. 2023 No.7). These Regulations impose requirements on producers who are established in Scotland to collect data on the packaging they supply to others, and, in some cases, to report some of that information to the Scottish Environment Protection Agency (SEPA).

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Cosmetics & Personal Care

Checking the authenticity of your raw materials

Today's consumers are paying more attention to the quality and especially the origins and traceability of the ingredients in cosmetic products. Given the complexity of the sources of supply, it is not always easy to meet these consumer demands.

Isotope ratios, the relative contents of the heavy and light forms of an element in a given sample, can be accurately measured in natural abundance by SNIF-NMR® (1) or by IRMS (2). Since these ratios are influenced by factors related to the environment or the synthesis of a product, they can provide information on the origin of compounds and allow for the detection of substitutions by chemically identical molecules from a different source.

The Eurofins network of laboratories is known for its development of the SNIF-NMR® method. This technique, in combination with IRMS, can provide a scientific guarantee of the authenticity of raw materials and ingredients.

Eurofins Cosmetics and Personal Care network of companies offers isotopic analysis to:

determine the natural or synthetic origin of a flavouring substance (e.g. vanillin).
differentiate between animal and vegetal origin (e.g. glycerol), terrestrial or marine origin (e.g. Chondroitin sulfate), and plant or animal origin (squalene/squalene)
verify vegetable sources of organic acids (Citric, malic tartaric, ascorbic, propionic etc.)

Eurofins Cosmetics & Personal Care can also develop bespoke solutions to meet your needs.

New volunteer and recruitment management software for all Eurofins Cosmetics & Personal Care cosmetic studies

New volunteer and recruitment management software for all our cosmetic studies is currently being deployed in all our cosmetic centers.

A website linked to an internal back-office simplifies the process for our volunteers and increases our visibility.

An online description of the studies as well as available pre-screening questionnaires simplify recruitment of volunteers and the quality of these candidates.

As a result, we have seen a rapid increase in the flow of new volunteer registrants since the launch of the website.

By 2024, the software will be deployed in Eurofins Cosmetics & Personal Care’s 24 clinical laboratories worldwide.

Because the privacy of our volunteers and the security of our clients' data is our number one priority, our sites guarantee:

total security of the data, utilising latest technologies and monitoring tools
“privacy by design" - all the tools necessary for the proper information of users and the application of the principles of the right to forget, withdrawal of consent, etc are embedded in the design of the software solution
total compliance with RGPD, HIPAA, Data Security Law China, and HDS secure hosting
development and quality validation carried out in accordance with the principles of GAMP 5 and good pharmaceutical practices for software development

Discover one of our new websites here.

Focus on anti-hair loss products testing

Many people are concerned about hair loss and, in more serious cases, alopecia. Hair loss can significantly impact self-esteem, however some targeted products may help.

The hair growth cycle is comprised of 3 successive phases, the anagen phase (growth), the catagen phase (rest), and the telogen phase (loss). Physiological loss is estimated at 30 to 100 hairs per day.

The two main causes of hair loss are androgenetic alopecia and telogen effluvium:

Androgenetic alopecia

The onset of clinical symptoms differ according to sex: symmetrical recession of the temporal edges in men, oval thinning of the vertex hair in women. Androgenetic alopecia chronic hair loss, starting quite early in forehead and temple area. Causes of Androgenetic alopecia may include genetic predisposition, especially in men, and hormonal effects.

Telogen effluvium

Telogen effluvium is a type of alopecia without any particular topography.

This is accute hair loss occurring 2 or 3 months after a triggering event (childbirth, cessation of breastfeeding… for women, acute infection, stress… for men and women).

Through its network of 19 laboratories specialised in hair testing, the Eurofins Cosmetics & Personal Care network can help you to develop performance products targeting the effects and causes of alopecia.

The duration of the test is between 1 to 3 months, with application of the product on the whole head at home, or controlled application in investigating centers on targeted areas.

Evaluation is based on clinical scoring (hair mass, volume…), self-evaluation by the subjects (hair loss, hair mass…), phototrichogram (photos of shaved minizones, counting of anagen, telogen and total hair density) and illustrative pictures.

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Softlines & Leather

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 nine new substances, the current list of SVHCs now contains 233 substances.

See below a table indicating the latest substances addition:

Nº	Substance name	EC number	CAS number	Reason for inclusion	Examples of use(s)
1	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)	While the substance itself is not registered under REACH, identification as an SVHC can be seen as a measure to avoid future non-advisable substitution.
2	2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol	201-236-9	79-94-7	Carcinogenic (Article 57 a)	As a reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxycoated circuit boards, printed circuit boards, paper and textiles.
3	4,4'-sulphonyldiphenol (Bisphenol S)	201-250-5	80-09-1	Toxic for reproduction (Article 57 c); Endocrine disrupting properties (Article 57 f – environment); Endocrine disrupting properties (Article 57 f – human health)	In the manufacture of pulp, paper and paper products, textile, leather or fur and chemicals.
4	Barium diboron tetraoxide	237-222-4	13701-59-2	Toxic for reproduction (Article 57 c)	In paints and coatings.
5	Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof	-	-	Very persistent and very bioaccumulative (Article 57 e)	As a flame retardant and a plasticiser for flexible polyvinylchloride and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings and adhesives.
6	Isobutyl 4-hydroxybenzoate	224-208-8	4247-02-3	Endocrine disrupting properties (Article 57 f – human health)	In the manufacture of substances and in the following products: coating products, fillers, putties, plasters, modelling clay and inks and toners.
7	Melamine	203-615-4	108-78-1	Equivalent level of concern with probable serious effects on human health (Article 57 f – human health); Equivalent level of concern with probable serious effects on the environment (Article 57 f – environment)	In polymers and resins, coating products, adhesives and sealants, leather treatment products, laboratory chemicals.
8	Perfluoroheptanoic acid and its salts	-	-	Toxic for reproduction (Article 57 c); Persistent, bioaccumulative and toxic (Article 57 d); Very persistent and very bioaccumulative (Article 57 e); Equivalent level of concern with probable serious effects on human health (Article 57 f – human health); Equivalent level of concern with probable serious effects on the environment (Article 57 f – environment)	While the substance itself is not registered under REACH, identification as an SVHC can be seen as a measure to avoid future regrettable substitution.
9	reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine	473-390-7	-	Very persistent and very bioaccumulative (Article 57 e)	Used in items used by professional workers (widespread use), in formulation or re-packing, at industrial sites and in manufacturing.

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 one tonne per producer or per importer per year. The notifications have to be submitted within six months from the date 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 on ECHA’s website.

France

Expansion of the categories of decoration elements for ERP

On 31^st December 2022, The Minister for Ecological Transition and Territorial Cohesion published the Order of December 23, 2022, amending the order of December 22, 2017 and approving an eco-organization in the furniture waste sector pursuant to article R. 543-252 of the environment code.

It indicates the expansion of decorative elements to 12 categories in the Environment Code. The new category includes textile decorative elements such as rugs, carpets, curtains, and sheers, as well as their accessories, regardless of the materials that make up these accessories.

This means that according to the principle of extended producer responsibility (REP), the management of waste from furnishing elements (DEA), including textile decorative elements, must be ensured by the producers of the said products. To fulfil their obligations, the latter must join an approved eco-organisation or set up an approved individual system. This decree completes the approval of the eco-organization on the scope of furnishing elements extended to textile decorative elements

Approved eco-organisation for textiles, shoes and household linen

On 28^th December 2022, The Minister for Ecological Transition and Territorial Cohesion published Order of 23 December 2022 approving an eco-organization of the sector with extended responsibility for the producer of waste textiles, shoes and household linen (TLC).

This decree approves the company EcoTLC - Refashion as an eco-organization until December 31, 2028.

According to the principle of extended producer responsibility (REP), the management of waste from textile products, shoes and household linen (TLC) mentioned in 11° of article L. 541-10-1 of the environment must be ensured by the producers of the said products. To fulfill their obligations, the latter must set up either an approved individual system or join an approved collective scheme.

New York Approves PFAS in Textiles Regulation

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

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

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.

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

Standards updates

See below a table summarising some recent ASTM standards updates:

Reference	Title
ASTM D3655-22	Standard Performance Specification for Men’s and Women’s Silver Knitted Overcoat and Jacket Fabrics
ASTM D3780-22	Standard Performance Specification for Men’s and Boy’s Woven Dress Suit Fabrics and Woven Sportswear Jacket, Slack, and Trouser Fabrics
ASTM D3782-22	Standard Performance Specification for Men’s and Boy’s Knitted Dress Suit Fabrics and Knitted Sportswear Jacket, Slack, and Trouser Fabrics
ASTM D6413/D6413M-22	Standard Test Method for Flame Resistance of Textiles (Vertical Test)
ASTM D3994-22	Standard Performance Specification for Woven Swimwear Fabrics
ASTM D4153-22	Standard Performance Specification for Men’s, Women’s, and Children’s Woven Handkerchief Fabrics
ASTM D3618-05 (2022)	Standard Test Method for Detection of Lead in Paint and Dried Paint Films
ASTM D6321/D6321M-22	Standard Practice for the Evaluation of Machine Washable T-Shirts
ASTM D4035-22	Standard Performance Specification for Knitted Necktie and Scarf Fabrics
ASTM D7020-22	Standard Performance Specification for Woven Blouse, Dress, Dress Shirt & Sport Shirt Fabrics
ASTM D4966-22	Standard Test Method for Abrasion Resistance of Textile Fabrics (Martindale Abrasion Tester Method)
ASTM D4970/D4970M-22	Standard Test Method for Piling Resistance and Other Related Surface Changes of Textile Fabrics: Martindale Tester

China

China Issues new and updated Product Standards

The Chinese Ministry of Industry and Information Technology has recently released various new and updated industry and national product standards. Please see Table 1 below:

Table 1:

Category	Standard
Textile & Apparel	FZ/T 81024-2022 – Woven Capes
Footwear	GB/T 43293-2022 – Shoe size

International

Updated requirements for ECO certifications

Every January, OEKO-TEX® publishes annual updates to the standards, as well as test criteria and limit values.

This year an update highlight is the general ban on the use of perfluorinated and polyfluorinated alkylated substances (PFAS / PFC) in textiles, leather and footwear for the STANDARD 100, LEATHER STANDARD and ECO PASSPORT certifications.

It will come into effect during the first quarter of 2023.

For more information, consult the official website here.

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Toys, Childcare & Hardlines

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 nine new substances, the current list of SVHCs now contains 233 substances.

See below a table indicating the latest substances additions:

Nº	Substance name	EC number	CAS number	Reason for inclusion	Examples of use(s)
1	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)	While the substance itself is not registered under REACH, identification as an SVHC can be seen as a measure to avoid future non-advisable substitutions.
2	2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol	201-236-9	79-94-7	Carcinogenic (Article 57 a)	As a reactive flame retardant and additive flame retardant in the manufacture of polymer resins, in products such as epoxycoated circuit boards, printed circuit boards, paper and textiles.
3	4,4'-sulphonyldiphenol (Bisphenol S)	201-250-5	80-09-1	Toxic for reproduction (Article 57 c); Endocrine disrupting properties (Article 57 f – environment); Endocrine disrupting properties (Article 57 f – human health)	In the manufacture of: pulp, paper and paper products, textile, leather or fur and chemicals.
4	Barium diboron tetraoxide	237-222-4	13701-59-2	Toxic for reproduction (Article 57 c)	In paints and coatings.
5	Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof	-	-	Very persistent and very bioaccumulative (Article 57 e)	As a flame retardant substance and as a plasticiser for flexible polyvinylchloride and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings and adhesives.
6	Isobutyl 4-hydroxybenzoate	224-208-8	4247-02-3	Endocrine disrupting properties (Article 57 f – human health)	In the manufacture of substances and in the following products: coating products, fillers, putties, plasters, modelling clay, and inks and toners.
7	Melamine	203-615-4	108-78-1	Equivalent level of concern with probable serious effects on human health (Article 57 f – human health); Equivalent level of concern with probable serious effects on the environment (Article 57 f – environment)	In polymers and resins, coating products, adhesives and sealants, leather treatment products, laboratory chemicals.
8	Perfluoroheptanoic acid and its salts	-	-	Toxic for reproduction (Article 57 c); Persistent, bioaccumulative and toxic (Article 57 d); Very persistent and very bioaccumulative (Article 57 e); Equivalent level of concern with probable serious effects on human health (Article 57 f – human health); Equivalent level of concern with probable serious effects on the environment (Article 57 f – environment)	While the substance itself is not registered under REACH, identification as an SVHC can be seen as a measure to avoid future non-advisable substitution.
9	reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine	473-390-7	-	Very persistent and very bioaccumulative (Article 57 e)	Used widely in items used by professional workers, in formulation or re-packing, at industrial sites, and in manufacturing.

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 one tonne per producer or per importer per year. The notifications have to be submitted within six months from the date 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 on ECHA’s website.

Closer to new European General Product Safety Regulation

On 21^st December 2022, the ‘final’ text of the new European General Product Safety Regulation (GPSR) was sent to the Chair of the European Parliament IMCO Committee.

Following an informal meeting on 28 and 29 November 2022 between the representatives of the three institutions (European Commission, Parliament and Council), a draft overall package was agreed by the Permanent Representatives’ Committee.

This 'final' text represents a substantial update from the current rules. Some of the key changes under the GPSR include:

Direct application to all Member States.
New accident reporting obligation in the EU.
Additional factors to take into account in an assessment of whether a product is safe.
Lays down new requirements for non CE marked products (e.g. some accessories) to align with requirements for CE marked products.
New requirements for online offers.
E-labelling (a digital form such as a QR code).
New requirements for advertising recalls and recall notices.
Lays down rules for recall remedies.
New obligations for online marketplaces.
Expanded role of Safety Gate (product recall notification and accident reporting).
Increased enforcement (particular products / product categories inspections by authorities).
Between others changes related to penalties, class actions and transition period of 18 months.

The legislation could be published in the Official Journal of the European Union around the second quarter 2023 with an enforcement date of the fourth quarter of 2024.

Designing products that last longer and can be repaired

On 15^th November 2022, the European Commission published the Resolution of 7 April 2022 on the right to repair (2022/2515(RSP)).

This regulation emphasizes that the effective right to repair should address aspects of the product lifecycle, for example: product design, key ethical principles of production, standardisation, consumer information, consumer rights and guarantees, and public procurement.

Another point that the Regulations emphasizes is that it balances the principles of sustainability, consumer protection and a highly competitive social market economy for green transition.

France

AGEC Law 2023

This year, there have already been changes in the French Market related to consumer products. Below is, a summary with some relevant points on selling products in France in 2023.

Replace disposable fast food dishes with reusable dishes.
Fast food restaurants must, as of January 1, 2023, use reusable tableware for meals and drinks served on site (cups, lids, plates, containers, cutlery).
Producers and/or those responsible for certain products are responsible for the waste they produce. They have the choice of setting up collective structures (eco-organisations) or an individual system for the management of waste from their products to comply the Extended Producer Responsibility (EPR).
Info-Tri signage (Logo Triman and sorting information) on products with the aim to make sorting more effective.
Prohibit the disposal of unsold non-food items and promote donations and recycling.
The in-store collection obligation.
Since January 1, 2023, the "AGEC" law has extended the in-store take-back obligations for toys, sports and leisure items, as well as DIY and garden items. The products can be brought back to the store in the collection bins provided.
The systematic printing of cash receipts, credit card receipts, and tickets distributed by automatic machines and purchase vouchers and promotional tickets will be prohibited.
Apply a reparability index and tend towards a durability index.
Facilitate repair and promote the use of spare parts from the circular economy.

For more information, consult the French Ministry of Ecological Transition and Territorial Cohesion website here.

Relevant publication related to ERP and Environmental Code

The latest publications in relation to Extended Producer Responsibility (ERP) and Environmental Code are summarised in the table below:

Date	Publication
13/12/2022	Order of July 26, 2022 amending the amended order of November 29, 2016 relating to the approval procedure and the specifications of eco-organisations in the household packaging sector.
14/12/2022	Order of 12 December 2022 relating to data from extended producer responsibility (REP) sectors.
15/12/2022	Decree No. 2022-1565 of December 14, 2022 relating to the terms and conditions of application of IV of Article L. 541-15-10 of the Environment Code.
18/12/2022	Order of December 8, 2022 setting the tariff provided for in Article R. 541-171 of the Environment Code for the fee relating to inter-sector communication actions of extended producer responsibility.
24/12/2022	Order of December 21, 2022 amending the order of December 26, 2017 approving an eco-organization in the furniture component waste sector pursuant to Article R. 543-252 of the Environment Code ( the company Eco-mobilier).
24/12/2022	Order of December 21, 2022 amending the order of May 5, 2017 approving an eco-organisation whose purpose is to take charge of packaging waste , the final holders of which are households under the conditions provided for in Articles R. 543 -53 to R. 543-65 of the environment code (ADELPHE).
24/12/2022	Order of December 21, 2022 amending the order of May 5, 2017 approving an eco-organisation whose purpose is to take charge of packaging waste, the final holders of which are households under the conditions provided for in Articles R. 543 -53 to R. 543-65 of the environment code (CITEO).
24/12/2022	Order of 23 December 2022 approving an eco-organisation in the extended responsibility sector of the producer of graphic papers (CITEO).

Italy

Ministerial Guidelines on environmental labeling published

On 21^st November 2022, the Ministry of the Environment and Energy Security (MASE) published the Ministerial Decree n. 360 of 28 September 2022, which adopts the Guidelines on environmental labeling pursuant to art. 219, paragraph 5, of the legislative decree 3 April 2006, n. 152, for the correct fulfillment of the packaging labeling obligations defined by Legislative Decree 116/2020.

Digital channels (App, QR code, EAN code, websites, etc.) can be an alternative to the physical affixing of information. Below are some options:

Completely replace physical labeling with a digital one.
Choose to communicate only some of the mandatory information via digital channels. For example, to print the identification coding of the material directly on the packaging, and refer to the consultation of digital channels for information on separate collection.
Report the mandatory information directly on the packaging, and refer to the consultation of digital channels for further additional and voluntary information about the environmental characteristics of the packaging.

The information reported on the digital channels must be in line with the regulatory provisions and be clear, direct, punctual and easy to interpret.

Germany

Updated national non- harmonised standards list

On 19^th December 2022, The German Federal Institute for Safety and Health at Work (BAUA) published the ProdSG Non-Harmonized Area - Part 1 National Standards. This document compiles Standards according to the Product Safety Act – ProdSG. After their determination by the Committee for Product Safety (AfPS) and the publication of the references by the Federal Institute for Occupational Safety and Health in the Joint Ministerial Gazette, these standards develop the presumption of conformity according to § 5 Para. 2 ProdSG.

For more information, consult the BAUA website here.

Spain

New composition requirements for containers and packaging

On 27^th December 2022, the Spanish Ministry for the Ecological Transition and the Demographic Challenge published the Royal Decree 1055/2022, of December 27, on packaging and packaging waste. This decree repeals Law 11/1997 that previously regulated these issues.

This royal decree establishes the legal requirements applicable to packaging and packaging waste, with the aim of preventing and reducing their impact on the environment throughout their entire life cycle.

The Decree entered into force on December 29, 2022, one day after its publication in the Official State Gazette. However, the new marking obligations outlined in article 13 will only apply from January 1, 2025.

Please find below a summary of the main points with which manufactures, importers or those otherwise responsible of packaging must comply:

Product producers or authorised representatives must register in the packaging section of the Register of Product Producers. Registration must be made within a period of three months from the date of entry into force of the aforementioned royal decree.
An annual declaration, corresponding to the containers that have been placed on the market in each calendar year, must be made. The period for reporting information for a given year will run from January 1 to March 31 of the following year.
Marking obligations detailing the packaging’s reuse or the container in which packaging waste must be deposited. The nature of the marking is not defined in the Royal Decree, so this is left to the discretion of the producer.
It is forbidden to indicate that the packaging is “respetuoso con el medio ambiente”(environmentally friendly) or any other equivalent text.
The decree regulates specifications of packaging "recyclability", the content of recycled material, and its compostable nature:
- Compostable plastic packaging must be designed in such a way that no non-compostable elements interfere with the recycling and composting process. It must bear a label indicating its quality based on the EN 13432:2001 standard.
- Marking packaging with the percentage of packaging material available for quality recycling is regulated. This information has been obtained through an auditable and certifiable evaluation, which must be reviewed at least every five years.
- Packaging may also be marked to indicate the percentage of recycled material it contains. This information must be certified by an accredited entity that issues certification from the National Accreditation Entity or the national accreditation body of any other Member State of the European Union, or in the case of products manufactured outside the European Union, any other accreditor with whom the National Accreditation Entity (hereafter ENAC) has an international recognition agreement.
- It will be presumed that the packaging meets the abovementioned criteria of it complies with the following standards:
  - UNE-EN 13427:2005 “Packaging and packaging. Requirements for the use of European standards in the field of containers and packaging and their waste”
  - UNE-EN 13428:2005 “Packaging and packaging. Specific requirements for manufacturing and composition. Prevention by reduction at source”
  - UNE-EN 13429:2005 “Packaging and packaging. Reuse”
  - UNE-EN 13430:2005 “Packaging and packaging. Requirements for containers and packaging that can be recovered through the recycling of materials”
  - UNE-EN 13431:2005 “Packaging and packaging. Requirements for containers and packaging that can be recovered through energy recovery, including the specification of the minimum lower calorific value"
  - UNE-EN 13432:2001 "Containers and packaging. Requirements for containers and packaging that can be recovered through composting and biodegradation. Test program and evaluation criteria for the final acceptance of the container or packaging"
- Packaging made with non-compostable plastic must incorporate a sufficient amount of recycled plastic to meet the objectives established in this Royal Decree. The amount of recycled plastic contained in the products must be certified by an accredited entity that issues certification under the UNE-EN 15343:2008 "Plastics. Recycled plastics. Traceability and conformity assessment of the recycling of plastics and recycled content”.
On January 1, 2023, the information on the environmental impacts and waste management obligations of the packaging must be available in shop, provided they have a useful area for exhibition and sale to the public equal to or greater than 300 meters squared in shop. These obligations will also apply to e-commerce platforms and retail businesses that make distance sales, which must clearly report the means used for the sale.
For single-use plastic bottles, the percentage of recycled plastic content in containers has been established for the period 2025-2030.
The obligation requires that businesses offer fruit and vegetables in bulk, prohibiting the sale of packaged in batches of less than 1.5 kilograms.
The conditions of the reuse of containers must be laid out, i.e. detailing the deposit, return and return systems or similar mechanisms, within the framework of the regulation established by the royal decree.

As of November 30, 2022, a proposal for a Commission Regulation on packaging and packaging waste has been in process, which will increase the requirements surrounding eco-desing and reuse.

Turkey

New statement on control of imports for toys and consumer products

On 31^st December 2022, Turkey’s Ministry of Commerce published two communications which establish the nation’s import control requirements for toys and some consumer products. They became effective on 1^st January 2023. Below a summary containing information on these new communications:

Communication on import control of toys (Product safety and audit: 2023/10)

This stablishes the nation’s import control of toys the Risk-Based Control System on Foreign Trade (TAREKS).

Communication on control of imports of consumer products (Product safety and audit: 2023/12)

This establishes a list of consumer goods with health and safety codes for control, and also requires certain products or materials to comply with specified restricted chemicals under Turkey REACH (Kimyasalların Kaydı, Değerlendirilmesi, İzni Ve Kısıtlanması Hakkında Yönetmelik (KKDIK)).

Some affected products include:

- Toilet seats for children
- Imitation jewelry
- Watches and straps
- Cases for cell phones and tablets
- TS EN 1273 Baby walking frames and TS EN 1466 Carry cots and stands
- TS EN 1400 Soothers for babies and young children
- TS EN 14350 Drinking equipment intended for young children
- TS EN 14988:2017+A1 Children’s highchairs
- TS EN 13138-3 Buoyant aids for swimming instruction

California Designates Nail Products Containing Toluene as a Priority Product

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.

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

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 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.

STURDY Act Passes as Part of 2023 Spending Bill

The Stop Tip-overs of Unstable, Risky Dressers on Youth Act (“STURDY Act”) has recently passed through the Congress as part of the 2023 omnibus spending bill. The STURDY Act will now supersede the U.S. Consumer Products Safety Commission (CPSC) final rule on the Safety Standard for Clothing Storage Units (CSUs) that was set to go into effect on May 24^th, 2023. The STURDY Act will require the CPSC to adopt a new rule to protect children from tip-over-related death or injury with:

tests that simulate the weight of children up to 60 pounds;
objective, repeatable, reproducible, and measurable tests or series of tests that simulate real-world use and account for impacts on clothing storage unit stability that may result from placement on carpeted surfaces, drawers with items in them, multiple open drawers, and dynamic force;
testing of all CSUs, including those 27 inches and above in height; and
warning requirements based on ASTM F2057-19, or its successor at the time of enactment, provided that the CPSC may strengthen the warning requirements of ASTM F2057-19, or its successor, if reasonably necessary to protect children from tip-over-related death or injury.

ASTM International will have 60 days to publish revisions to the ASTM F2057 standard to meet the requirements of the STURDY Act outlined above. The CPSC will then have 90 days to determine whether to adopt the updated ASTM F2057 standard in whole or in parts and promulgate a final consumer product safety rule that meets the requirements of the STURDY Act. The new CSU product safety rule will go into effect 120 days after the date of the promulgation or such a later date as the CPSC determines appropriate.

CPSC’s Custom Window Covering Safety Rule Not Effective While Court Case Pending

On November 30^th, 2022, the Window Covering Manufacturers Association (WCMA) filed a lawsuit to challenge the Consumer Product Safety Commission’s (CPSC) rule, Safety Standard for Operating Cords on Custom Window Coverings (16 CFR 1260), claiming that the rule does not substantively advance child safety. On January 10^th, 2023, the U.S. Court of Appeals for the D.C. Circuit granted the motion by WCMA to stay the CPSC rule. As a result, the CPSC rule that was set to come into force on May 30^th, 2023 will not take effect while WCMA’s lawsuit against CPSC is pending.

US Passes Modernization of Cosmetics Regulations Act

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

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:

Category	Standard	Effective Date
Food Contact Materials	TIS 2622-2556 Fluropolymer-Coated Utensils for Food	April 2^nd, 2023

International

Miscellaneous technical publications relating to food contact materials

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

Date

Entity

Publication

17/11/2022

MERCOSUR

MERCOSUR Members (Argentina, Brazil, Paraguay and Uruguay) have to transpose the amendment into their national law by May 16, 2023.

05/01/2023

Brazilian Health Regulatory Agency (ANVISA)

Draft resolution number 1134, 23 December 2022

This Draft Resolution proposes the modification of the current

regulatory framework regarding the technical regulation on provisions for packaging, coatings, utensils, lids and metallic equipment in contact with food. (G/TBT/N/BRA/1464)

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