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Regulatory updates 03-2023

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Chemical

Europe

PFAS restriction proposal: Europe’s largest substance banning project ever

On 13^th January 2023, a restriction proposal was submitted to the ECHA (European Chemical Agency) by five European authorities (Denmark, Germany, the Netherlands, Norway and Sweden). These authorities worked together on this proposal to limit the use of PFAS (Per- and polyfluoroalkyl substances) in the EU, having extensively studied PFAS, their use and the risks they pose to humans and the environment over the past three years. This stage involved consulting scientific literature and various requests for information from relevant businesses, public authorities and organisations.

On 7^th February 2023, this new restriction proposal was published by the ECHA. The restriction proposal seeks to ban both the use and production of PFAS in order to reduce the risks these substances pose to humans and the environment.

PFAS is a group of synthetically produced chemicals that are widely found in commonly used products. Common to all PFASs is that they break down very slowly in the environment and can damage the environment, as well as threatening human health. More than 10,000 different types of PFAS exist.

PFAS are found in a range of everyday products they are used to give water and dirt-repellent properties, among others. They are, therefore, common in many consumer products, for example water-resistant textiles, food packaging, non-slip coatings on frying pans, coolants for refrigerators and air conditioners, ski lubrication, electronic devices, and paints. PFAS are also used in industrial activities such as chrome plating, foam suppressors, and in fluorine-containing plastic materials.

Hereinafter, the main stages in the process of banning the use of PFAS will be:

During the first stage, ECHA's Scientific Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) will initially discuss whether the submitted restriction proposal complies with the legal requirements under REACH at their their meetings in March 2023. After that, the committees will examine the proposal from a scientific perspective.
The next stage is a six-month public consultation which is expected to start on March 22, 2023. Anyone may submit information or give an opinion about the proposal.
Afterwards, two ECHA scientific committees – the Risk Assessment Committee (RAC) and the Socio-Economic Assessment Committee (SEAC) – will present their opinions. This stage is to be completed within 12 months according to REACH Regulation.
Finally, the European Commission will draft a definitive proposal for a Member State vote. The ban is subsequently expected to enter into force in 2025.

Summary of key dates in the process:

Year	Process
2020	January: First meeting May-July: Call for evidence
2021	July-October: 2^nd stakeholder consultation October: Start of drafting of proposal
2023	13^th January 2023: Submission of the dossier with the new proposal
	7^th February 2023: The new proposal is published by ECHA.
	22^nd March: Open consultations for 6 months (until 22^nd September 2023)
	5^th April: online information session by ECHA
2024	Opinion of Committees
2025	COM decision Entry into force
2026/2027	Restriction becomes effective

Summary of the restriction proposal:

Per- and polyfluoroalkyl substances (PFASs) defined as: Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it).

Conditions of restriction:

Shall not be manufactured, used or placed on the market as substances on their own;
Shall not be placed on the market in:
- another substance, as a constituent;
- a mixture;
- an article.

in a concentration of or above:

- 25 ppb for any PFAS as measured with targeted PFAS analysis (polymeric PFASs excluded from quantification).
- 250 ppb for the sum of PFASs measured as sum of targeted PFAS analysis, optionally with prior degradation of precursors (polymeric PFASs excluded from quantification).
- 50 ppm for PFASs (polymeric PFASs included). If total fluorine exceeds 50 mg F/kg the manufacturer, importer or downstream user shall upon request provide to the enforcement authorities a proof for the fluorine measured as content of either PFASs or non-PFASs.

Paragraphs 1 and 2 shall apply 18 months from entry into force of the restriction.

A number of derogations, reporting requirements and management plans implementation have been also provided in the conditions of restriction (Paragraphs 4 to 9). For further information on these, please consult the complete Annex XV restriction report at ECHA website.

For more information, consult the ECHA’s website here.

Publication of the best available techniques for the Chemical industry

Chemical industry plants in the EU will have to comply with new legal requirements adopted under the EU Industrial Emissions Directive to reduce their environmental impact and in doing so become a more competitive and greener sector. The new requirements, together with the EU Chemicals Strategy for Sustainability, aim to increase the protection of human health and the environment while boosting the competitiveness of the industry.

For this reason, on 12^th December 2022, the Commission Implementing Decision (EU) 2022/2427 was published, establishing the best available techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament and of the Council on industrial emissions, for common waste gas management and treatment systems in the chemical sector.

This new Commission Implementing Decision wants to increase the protection of human health and the environment. The main points are:

Stricter levels for volatile organic compounds (VOCs).
A new approach based on a management system for preventing, reducing and quantifying diffuse emissions.
New environmental criteria for specific emission caps for VOCs and vinyl chloride monomers (VCMs).
The new criteria also reinforces monitoring and control measures to track the evolution of the expected emission reductions.

The chemical industry has four years to adapt existing installations. New facilities must comply immediately.

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
17/01/2023	Updated SCIP Candidate List package available. A new package for SCIP was released that it is aligned with each inclusion of additional substances on the Candidate List.	More information on ECHA’S website here.
23/01/2023	On 1^st May 2023, new and amended checks related to new registrations and updates of existing ones will take effect and will apply to both. The new and amended checks concern: Substance identity Standard information requirements based on Annexes VII-XI In parallel, limited revisions have been made to the completeness check in other areas, such as information on use.	More information on ECHA’S website here.
23/01/2023	The European Commission amended some of the information requirements for registering chemicals under REACH in 2021 and 2022. As of 1^st May 2023, ECHA will start checking both new registrations and updates to existing ones against the revised requirements.	More information on ECHA’s website here.
24/01/2023	A new manual on how to share information when preparing a chemical safety report has been published.	More information on ECHA’s website here.
24/01/2023	The ECHA has published IUCLID structured datasets for 348 approved pharmaceuticals, with results from non-clinical animal studies and human information.	More information on ECHA’S website here.
26/01/2023	Publication of Commission Regulation (EU) 2021/57 of 25 January 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead in gunfire in or around wetlands (C/2021/318).	More information on ECHA’S website here.
07/02/2023	Publication of Annex XV Restriction report: Per- and polyfluoroalkyl substances (PFASs).	More information on ECHA’S website here.
15/02/2023	The ECHA has launched a consultation on 13 applications for authorization, covering 14 uses of: Chromium trioxide (EC 215-607-8, CAS 1333-82-0): Used in functional chrome plating, functional chrome plating with decorative character, passivation of electrolytic tinplate (ETP) Sodium dichromate (EC 234-190-3, CAS 10588-01-9): Passivation of electrolytic tinplate (ETP)	More information on ECHA’S website here.
15/02/2023	REACH-EN-FORCE-11 in Operational phase. REF- 11 has aims to assess whether duty holders have updated and provided safety data sheets according to the new requirements of Annex II to REACH. In 2023, the operation phase will take place and the results will be reported in 2024.	More information on ECHA’S website here.
15/02/2023	The ECHA opened the call for comments and evidence on the presence of Substances which are classified as carcinogen, germ cell mutagen or reproductive toxicant category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008CMR in Childcare articles.	More information on ECHA’S website here.

Other interesting links about REACH from the ECHA’s website

New hazard classes under the CLP for endocrine disruptors

On 19^th December 2022, the European Commission adopted a Delegated Act to introduce new hazard classes under the CLP for endocrine disruptors, which also applies to chemicals that do not break down in the environment. The aim is to increase protection of human health and the environment. The legislative proposal amending the CLP Regulation facilitates:

Better and faster processes for flagging hazards of chemicals placed on the EU market.
Improved communication about chemical hazards, including online, through simpler and clarified labelling and advertising requirements.
The right for the Commission to develop classification proposals on potentially hazardous substances, in addition to Member States and industry.
First ever specific rules for refillable chemical products, such as home care chemicals, sold in bulk in a safe way.

This Commission Delegated Act is subject to the approval of the European Parliament and Council and it is expected enter into force in 2023.

Other interesting links about CLP from the ECHA’s website

European Initiatives related to POP legislation

Recent initiatives by the European Commission related to POP legislations include:

Initiative

State

Persistent organic pollutants – perfluorohexane sulfonic acid (PFHxS).

This initiative amends Annex I to the Regulation (EU) 2019/1021, which mplements the EU’s international commitments under the Stockholm Convention on persistent organic pollutants to include PFHxS, its salts and PFHxS-related compounds as substances that are subject to certain restrictions.

Feedback period was 9^th February 2023 until 9^th March 2023.

Miscellaneous technical publications relating to Chemicals

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

Date	Country/ Region	Entity	Publication
23/01/2023	France	Ministère de la transition écologique	Order on the identification of hazardous substances in waste-generating products (2023/26/F). In order to enable citizens to make informed consumption choices, the Order establishes a list of substances whose level of concern is comparable to that of substances of very high concern, in accordance with Decree No 2021-1285 of 1 October 2021 on the identification of hazardous substances in waste-generating products. The substances on this list established must be communicated to consumers as soon as they are present in more than 0.1 % by mass of waste-generating products, in accordance with Decree No 2022-748 of 29 April 2022 on consumer information about the environmental qualities and characteristics of waste-generating products.
23/01/2023	France	Ministère de la transition écologique	Order on the provision of information on the presence of hazardous substances in waste-generating products by means of an application (2023/25/F). The presence of hazardous substances in waste-generating products must be made available to the public in a dematerialised format or via applications in accordance with the provisions of Article R. 541-222. The Order establishes a list of applications to inform consumers. This method of communicating information via applications is provided for in the Environmental Code in Article R. 541-222 (notified by Decree No 2022-748 of 29 April 2022 on consumer information on the environmental qualities and characteristics of waste-generating products). The applications must be designated by an order of the Minister for the Environment.
08/01/2023	International	IFRA (The International Fragrance Association)	REACH Exposure scenarios for fragrance substances. The aim of this guidance is to provide registrants of fragrance substances in REACH with a standardised methodology of describing Identified Uses and preparing Exposure Scenarios for the entire lifecycle.
25/01/2023	France	Ministère de la Transition écologique et de la Cohésion des territoires	First stage of the Ministerial Action Plan on "PFAS" chemical substances: Launch of the consultation on a draft ministerial decree providing for the monitoring of "PFAS" in aqueous discharges from the industrial sectors concerned.
13/02/2023	France	Ministère de la Transition écologique et de la Cohésion des territoires	France challenges the judgment delivered by the General Court of the European Union. On Wednesday February 8^th2023, the French government announced that it was appealing the judgment of November 23, 2022 of the General Court of the European Union (TEU) annulling the delegated regulation of the European Commission concerning the classification and labeling of titanium dioxide as a suspected carcinogen (category 2) by inhalation for certain powder forms. France continues to defend the classification of titanium dioxide as a suspected carcinogen at European level.

UK legislation for Explosives Precursors substances

On 23^rd January 2023, the Statutory Instruments 2023 No.63 the Control of Explosives Precursors and Poisons Regulations 2023 was published.

These Regulations concern the supply of regulated and reportable substances which are regulated as explosive precursors.

It amends Regulation 2 of the Control of Poisons and Explosives Precursors Regulations 2015 (S. I. 2015/966) by removing references to licenses issued or recognised in accordance with a provision of European Union law that has now been repealed.

This way, it indicates the UK requirements on persons who are either involved in the supply of these kind of substances or who operate an online marketplace that is used by suppliers to make supplies of such substances.

It also contains amendments to the list of regulated and reportable substances.

California Adds 3 Carcinogenic Chemicals to Prop 65 List

California’s Office of Environmental Health Hazard Assessment (OEHHA) announced the listing of 3 new carcinogenic chemicals on the Proposition 65 list, effective January 27^th, 2023. Businesses have until January 27^th, 2024 to comply with Proposition 65’s clear and reasonable warning requirements. Please see Table 1 below for the list of chemicals added:

Table 1:

Chemical	CAS #	Type of Toxicity	Listing Date
Glycidyl methacrylate cancer	106-91-2	Cancer	January 27^th, 2023
1-Bromo-3-chloropropane	109-70-6	Cancer	January 27^th, 2023
1-Butyl glycidyl ether	2426-08-6	Cancer	January 27^th, 2023

Sustainability, environmental and circular economy

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

Date	Country/ Region	Publication
20/02/2023	Europe	Environmental impact of imaging equipment, including consumables. In line with the European Green Deal objectives on efficient use of resources, this initiative aims to ensure that: imaging equipment, such as printers, is designed to be energy and resource-efficient; consumers have the information needed to use their devices sustainably, including through maintenance and repair; the generation of waste through the use of consumables (e.g. ink cartridges) is minimised.
25/01/2023	France	Ministry of Ecological Transition and Territorial Cohesion published a news related to industrial plastic pellets. Faced with recent events that have affected several beaches in Pays de la Loire and Brittany, and in pursuit of the measures taken within the framework of the anti-waste law, the Government is strengthening its commitment to fight against the dispersion in the environment of industrial plastic pellets.
01/01/2023	Italy	The deferral of plastic tax. On 1^st January 2023, the Italy’s plastic tax should have entered into force, but the budget law for 2023 has provided the deferral of plastic tax to January 2024. This tax comes from the Law no. 160/2019 (Article 1, paragraphs 634 – 658) which sets the obligation to submit the declaration and pay the tax to the italian customs and monopolies agency at quarterly intervals, as well as subjective and objective requirements, scope of application and penalties applicable. The plastic tax is intended as a measure to discourage the consumption of single-use plastic products named “MACSI” (manufatti in plastica con singolo impiego). The amount of the tax is €0.45 per kilogram of virgin plastic contained. The tax does not apply to plastic material obtained from recycling processes, medical devices or those used to store and protect medical preparations. Compostable plastic in accordance with DIN EN 13432 is also excluded. The declaration and pay the plastic tax is mandatory and for non-resident entities in Italy is necessary to appoint a tax representative in Italy.
08/02/2023	France	Ministry of Ecological Transition and Territorial Cohesion published a news related to disposable tableware in fast food. Since January 1, 2023, France has become the first country in the world to ban disposable tableware for on-site catering.
17/01/2023	France	The Ministry of Ecological Transition and Territorial Cohesion published a document on plastics. This document provide information and questions and answer about plastic material in general and related to packaging.
02/02/2023	Italy	Extended responsibility of the producer textile in Italy. On 3^rd march 2023, the public consult related to draft decree which identifies obligations in the chain of textile products for clothing, footwear, accessories, leather goods and home textiles was closed. This draft decree has as the aim of promoting textile product sustainability and reducing environmental impact. The Minister of the Environment and Energy Security (MASE), in agreement with the Minister of Enterprise and "Made in Italy", has in fact prepared a draft decree which, in line with the "National Strategy for the Circular Economy", introduces some important news for the supply chain of textile products for clothing, footwear, accessories, leather goods and home textiles. The main points of this draft decree are: The producer takes charge of the financing and organization of the collection, initiation and preparation for re-use, recycling and recovery of waste deriving from textile products. The producer will be able to fulfill the obligations by setting up a management system in collective or individual form. The payment of an environmental contribution. The sustainability of the product. Products suitable for reuse and repair, containing recycled materials, technically durable and easily repairable. Eco-design measures: the use of biocompatible textile fibers and natural materials, the elimination of dangerous components and substances also with reference to microplastics released into the environment, the reduction of quality defects that lead the consumer to get rid of it, but also the use of fiber and fabric mixing techniques that favor adaptability to multiple uses and repairability. A digital labeling system that describes characteristics and fiber composition, indicating non-textile parts of animal origin. On other hand, the Coordination Center for Textile Recycling (CORID) was set up. It made up of all the individual and collective management systems recognized by the Ministry. For more information, consult the MASE ‘s website here.
27/01/2023	Europe	Transition pathway for the chemical industry. European Chemical Industry Council (Cefic) and European Commission publish roadmap to incorporate EU goals for the green and digital transformation into the chemicals sector by 2050; defines nearly 200 actions for the chemical industry with technological investments, and regulatory steps necessary; implementation expected to begin spring 2023.
31/01/2023	Europe	New product priorities for Ecodesign for Sustainable Products. The European Commission opened the published consultation related to Ecodesign for sustainable Products. It aims to make products sold in the EU subject to performance and information-related requirements, to ensure greater sustainability. The Commission seeks views on the categories of new products and measures to address first, so that it can set priorities transparently and inclusively. For more information, consult the European Commission website here.

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Cosmetics & Personal Care

Consider the rinsability of your hair products for better sustainability

Water scarcity affects almost two thirds of the world’s population. Thus, consumers are becoming more and more aware of the importance of saving water, asking for eco-friendly products that require less rinsing without compromising product performance.

At Eurofins Cosmetics & Personal Care, we are developing a triple testing approach towards water-smart products: instrumental, clinical and consumer testing. These tests complement one another and allow you to make claims about the rinsability of your product.

As part of the instrumental approach, rinsing time measurements are performed by an experienced technician and applied by standardised gesture. The efficiency of the rinsing can be verified by the following criteria: no visual foam, no foam after massage, no foam after combing, and clear rinse water.

To assess consumer perception, panelists evaluate rinsability. Consumer perception can be combined with sensory evaluation, e.g. the absence of greasy film, particularly for conditioners and masks.

We also carry out clinical studies to test the rinsability of your cosmetic products.

Eurofins Cosmetics & Personal Care has a strong network of 19 haircare laboratories to help you develop new eco-friendly and sustainable hair products.

ASEAN Regulation and Cosmetic Regulatory Compliance

ASEAN Cosmetic Directive, along with its annexes and amendments, regulate the cosmetic market in ASEAN (Association of Southeast Asian Nations), which comprises 10 member states: Malaysia, Singapore, Thailand, the Philippines, Brunei, Vietnam, Laos, Burma and Cambodia.

It is a directive, which means that each country must transpose it into national law in order for it to be applied.

It also stipulates that any product introduced on the ASEAN market must be subject to a cosmetic product file, which must include a safety report and information on the product’s formula. It is also necessary to notify the competent authorities in all member states where the product will be marketed.

In addition, each ASEAN country has its own specific legislation. Our regulatory teams can also provide support regarding local legislation. We will help you to set up an appropriate testing plan, leveraging our network of clinical and analytical laboratories to perform the required tests.

Teleconsultation in cosmetic clinical studies

The COVID-19 pandemic and the forced closure of clinical study centres inspired Eurofins Cosmetics & Personal Care to reinvent our study centres and experiment with the feasibility of conducting remote virtual clinical studies under dermatological control.

Did you know that is is possible to conduct qualitative clinical studies remotely? Done properly, teleconsultation scoring and face-to-face scoring have comparable results. However, the quality of the remote evaluations depends on the implementation of specific tools and how well the evaluators are trained in teleconsultation. For this reason, a training process for tele-assessment is put in place for the assessors, in the same way as it is for face-to-face scoring, to allow you to reap the benefits.

Teleconsultation allows studies to be conducted with subjects from different regions and countries, and has the additional advantage of facilitating collaboration with external experts, making it possible to benefit from professionals with diverse specialties.

Eurofins Cosmetics & Personal Care offers a strong network of experts across its 24 clinical laboratories.

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Softlines & Leather

Europe

Publication of the best available techniques for textile industry

Textile industry plants in the EU will have to comply with new legal requirements adopted under the EU Industrial Emissions Directive to reduce their environmental impact and in doing so become a more competitive and greener sector. This is inside the EU strategy for sustainable and circular textile.

For this reason, on 20^th December 2022, the Commission Implementing Decision (EU) 2022/2508 was published, establishing the best available techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament and of the Council on industrial emissions.

The new Commission Implementing Decision affects the wet processing of textiles as bleaching, dyeing to finishing treatment. Other main points in these new legal requirements are:

The emissions to air and to water pollutants such as formaldehyde, total volatile organic compounds (TVOC), dust, ammonia (emissions to air), or metals (emissions to water).
Energy efficiency and resource efficiency (water consumption, chemicals consumption, waste generation).
The search of the chemical substances alternatives less dangerous for the environmental and human.

The textile industry has four years to adapt existing installations. New facilities must comply immediately.

Commission demands for France regarding waste sorting labelling

The provision of waste sorting information to consumers is not harmonised across Europe. Each country can adopt its own criteria according to the European Waste Framework Directive.

The imposition of national-specific labelling requirements can break the principle of free movement of goods and can lead to counterproductive environmental effects, such as the increase of materials and sizes of packaging because of additional waste information.

On 15^th February 2023, the European Commission opened an infringement procedure (INFR(2022)4028) to France for the following reasons:

The French law was not notified to the Commission at a draft stage, prior to adoption.
An insufficient analysis of options for providing the sorting waste information/failure to look for other options that are less restrictive to trade between Member States.

The European Commission wants to ensure that the French waste sorting labelling complies with the principle of the free movements of goods.

The French authorities have two months to respond to the concerns raised by the Commission.

Italy

Extended responsibility for textile producers in Italy

On 3^rd March 2023, the public consult related to a draft decree which identifies obligations in the chain of textile products for clothing, footwear, accessories, leather goods and home textiles was closed.

This draft decree has aims to promote textile product sustainability and reduce the environmental impact of textiles. The Minister of the Environment and Energy Security (MASE), in agreement with the Minister of Enterprise and "Made in Italy", has in fact prepared a draft decree which, in line with the "National Strategy for the Circular Economy", introduces some important measures for the supply chain of textile products for clothing, footwear, accessories, leather goods and home textiles.

The main points of this draft decree are:

The producer takes charge of financing and organisation the collection, initiation and preparation for re-use, recycling and recovery of waste deriving from textile products.
The producer will be able to fulfill the obligations by setting up a management system in collective or individual form.
The payment of an environmental contribution.
The sustainability of the product; products suitable for reuse and repair, containing recycled materials, technically durable and easily repairable.
Eco-design measures: the use of biocompatible textile fibers and natural materials, the elimination of dangerous components and substances, also with reference to microplastics released into the environment, the reduction of quality defects that make the consumer inclined to dispose rid of the item, and the use of fiber and fabric mixing techniques that favour multi-purpose adaptability and repairability.
A digital labeling system that describes characteristics and fiber composition, indicating non-textile parts of animal origin.

Furthermore, the Coordination Center for Textile Recycling (CORID) has been set up. This comprises all the individual and collective management systems recognized by the Ministry.

For more information, consult the MASE ‘s website here.

Standards updates

See below a table summarising some recent ASTM standards updates:

Reference	Title
ASTM D1610-18 (2023)	Standard Practice for Conditioning Leather and Leather Products for Testing
ASTM D1813-13 (2023)	Standard Test Method for Measuring Thickness of Leather Test Specimens
ASTM D1912-00 (2023)	Standard Test Method for Cold-Crack Resistance of Upholstery Leather
ASTM D2097-03 (2023)	Standard Test Method for Flex Testing of Finish on Upholstery Leather
ASTM D2099-14 (2023)	Standard Test Method for Dynamic Water Resistance of Shoe Upper Leather by the Maeser Water Penetration Tester
ASTM D2208-16 (2023)	Standard Test Method for Breaking Strength of Leather by the Grab Method
ASTM D2322-14 (2023)	Standard Test Method for Resistance of Shoe Upper Leather to Artificial Perspiration

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Toys, Childcare & Hardlines

Europe

New Guidance for classification toys for children under or above 36 months

On 2^nd February 2023, the European Commission published new guidance on the classification of toys for children under three or three years and over.

The aim of Guidance Document No 11 is to help classify toys intended for children under or above 36 months of age with examples and pictures to facilitate the decision-making. Toy categories for which specific guidelines are already available are not included nor toy categories which are clearly intended for children three years and older.

The new guidance has added twelve more categories to the existing ones (dolls, soft and stuffed toys and puzzles). In total, the following 15 categories are as follows:

Puzzles
Dolls
Soft and stuffed or partially stuffed toys:
- Soft and stuffed or partially stuffed toys
- Squishies
Fidget toys
Modeling clay/dough, slime, soap bubbles
Movable/wheeled toys
Play scenes, constructed models and construction toys
Game sets and board games
Toys intended to be entered
Toys intended to bear the mass of a child
Toy sports equipment and balls
Hobby horse/stick horse
Push-pull toys and pull-along toys
Audio/visual equipment
Toy figures and other toys

The main factors and considerations that the guideline indicates could be used to determine whether a toy is intended for children under 36 months are as follows:

The psychology of children of under three years, particularly their need to “cuddle”;
Their attraction to objects “which are like them”;
Their preference to imitate adults and their activities;
Their mental development, particularly their lack of capacity for abstraction, low level of knowledge, limited patience, etc.;
Their less developed physical abilities in terms of ease of movement, manual dexterity, etc;
The children's aptitudes to use a toy; if this use can start before 36 months of age and continue thereafter, the toy has to be appropriate for children under 36 months of age;
If a toy involves small parts;
Warnings on a toy must not be present on toys that meet the criteria for under 36 months of age while at the same time present risks for children of that age.

Commission demands for France regarding waste sorting labelling

The provision of waste sorting information to consumers is not harmonised across Europe. Each country can adopt its own criteria according to the European Waste Framework Directive.

On 15^th February 2023, the European Commission opened an infringement procedure (INFR(2022)4028) to France for the following reasons:

The French law was not notified to the Commission at a draft stage, prior to adoption.
An insufficient analysis of options for providing the sorting waste information/failure to look for other options that are less restrictive to trade between Member States.

The European Commission wants to ensure that the French waste sorting labelling complies with the principle of the free movements of goods.

The French authorities have two months to respond to the concerns raised by the Commission.

Technical publications relating to consumer products

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

Date

Entity

Publication

31/01/2023

European Commission

The European Commission published a draft JRC technical report about the preliminary study on new product priorities related to Ecodesign for Sustainable Products Regulation (ESRP). This Joint Research Centre (JRC) report aims to suggest a number of product groups and horizontal measures that may be suitable candidates for prioritisation under ESPR, once it enters into force.

For more information, consult the official publication on the European Commission website here.

Public European initiatives

The latest consultations by the European Commission related to chemicals are as follows:

Date

Publication

31/01/2023

New product priorities for Ecodesign for Sustainable Products

The European Commission opened the feedback and consultation period to compile opinions related to the European proposal on Ecodesign for Sustainable Products. This way, the European Commission will be able to set measures and priorities for categories of new products.

08/02/2023

Judicial cooperation in civil and commercial matters – authorisation to negotiate a bilateral agreement

The European Commission opened the feedback period until 5 April 2023 to compile opinions related to consumers, employment and social affairs, justice, and fundamental rights.

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
19/01/2023	Italian Minister of Health	Italy updates Stainless steels requirements The Decree of the Minister of Health No. 208 of November 25, 2022 was issued, which amends the Decree of the Minister for Health of March 21, 1973 on ‘Hygiene rules for packaging, containers and utensils intended to come into contact with foodstuffs or personal use products’ in relation to stainless steels. It came into effect on February 3, 2023.
01/01/2023	France’s Ministry for Ecological Transition	French mineral oil requirements On January 1, 2023 new French mineral oil requirements came into effect, implementing, in two phases, restrictions regulating mineral oil in ink for packaging and printed paper. Decree of April 13, 2022 indicates: Until December 31, 2024, a ban on the use of mineral oils applies if the mass concentration in the ink of mineral oil aromatic hydrocarbons (MOAH) is greater than 1%. As of January 1, 2025, a ban on the use of mineral oils applies: for MOAH, if the mass concentration in the ink of these substances is greater than 0.1% or the mass concentration in the ink of compounds with 3-7 aromatic rings is greater than one part per million (ppm); for hydrocarbons saturated with mineral oil (MOSH), if the mass concentration in the ink of these substances is greater than 0.1%.
23/01/2023	World Trade Organization (WTO)	A draft European regulation related to food contact plastics was announced (G/SPS/N/EU/611). It amends Annex I to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, as regards changes to substance authorisations and the addition of new substances. One of main changes is a decrease to the specific migration limit of DBP, BBP and DEHP and new requirements for the restriction of group substances.
01/02/2023	Germany’s Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR)	BfR updated the following Recommendations for food contact paper and board, silicone and rubber materials in articles: XV ‘Silicones’ XXI ‘Commodities Based on Natural and Synthetic Rubber’ XXI/1 ‘Commodities based on natural and Synthetic Rubber in Contact with Food’ XXXVI ‘Paper and Board for Food Contact’ XXXVI/1 ‘Cooking Paper, Hot Filter Paper and Filter Layers*’ XXXVI/2 ‘Paper and Paperboard for Baking Purposes’

Standards updates

The following table summarises the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):

(*) Date of withdrawal: the latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

CEN
Reference	Title	*Date of withdrawal()**	Supersedes
EN 1888-2:2018+A1:2022	Child care articles - Wheeled child conveyances - Part 2: Pushchairs for children above 15 kg up to 22 kg	2023-06-30	EN 1888-2:2018/FprA1:2022 EN 1888-2:2018
EN 13451-11:2022	Swimming pool equipment - Part 11: Additional specific safety requirements and test methods for moveable pool floors and moveable bulkheads installed in pools for public use	2023-06-30	EN 13451-11:2014
EN ISO 8098:2023	Cycles - Safety requirements for bicycles for young children (ISO 8098:2023)	2023-07-31	EN ISO 8098:2014
EN ISO 4210-1:2023	Cycles - Safety requirements for bicycles - Part 1: Vocabulary (ISO 4210-1:2023)	2023-07-31	EN ISO 4210-1:2014
EN ISO 4210-2:2023	Cycles - Safety requirements for bicycles - Part 2: Requirements for city and trekking, young adult, mountain and racing bicycles (ISO 4210-2:2023)	2023-07-31	EN ISO 4210-2:2015
EN ISO 4210-3:2023	Cycles - Safety requirements for bicycles - Part 3: Common test methods (ISO 4210-3:2023)	2023-07-31	EN ISO 4210-3:2014
EN ISO 4210-4:2023	Cycles - Safety requirements for bicycles - Part 4: Braking test methods (ISO 4210-4:2023)	2023-07-31	EN ISO 4210-4:2014
EN ISO 4210-5:2023	Cycles - Safety requirements for bicycles - Part 5: Steering test methods (ISO 4210-5:2023)	2023-07-31	EN ISO 4210-5:2014
EN ISO 4210-6:2023	Cycles - Safety requirements for bicycles - Part 6: Frame and fork test methods (ISO 4210-6:2023)	2023-07-31	EN ISO 4210-6:2015
EN ISO 4210-7:2023	Cycles - Safety requirements for bicycles - Part 7: Wheel and rim test methods (ISO 4210-7:2023)	2024-07-31	EN ISO 4210-7:2014
EN ISO 4210-8:2023	Cycles - Safety requirements for bicycles - Part 8: Pedal and drive system test methods (ISO 4210-8:2023)	2024-07-31	EN ISO 4210-8:2014
EN ISO 4210-9:2023	Cycles - Safety requirements for bicycles - Part 9: Saddles and seat-post test methods (ISO 4210-9:2023)	2024-07-31	EN ISO 4210-9:2014
EN 16105:2023	Paints and varnishes - Laboratory method for determination of release of regulated dangerous substances from coatings in intermittent contact with water	2023-07-31	EN 16105:2011
CEN/TS 927-9:2023	Paints and varnishes - Coating materials and coating systems for exterior wood - Part 9: Determination of pull-off strength	Not available	CEN/TS 927-9:2018
EN ISO 22553-10:2023	Paints and varnishes - Electro-deposition coatings - Part 10: Edge protection (ISO 22553-10:2022)	2023-07-31
EN 927-14:2023	Paints and varnishes - Coating materials and coating systems for exterior wood - Part 14: Determination of tensile properties of coating films	2023-07-31

France

Relevant publication related to ERP and Environmental Code

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

Date	Publication
07/02/2023	Frequently asked questions (FAQ) were published relating to consumer information on the qualities and environmental characteristics of waste-generating products pursuant to article 13-I of the AGEC law and Decree No. 2022-748 of April 29, 2022 by Ministry of Ecological Transition and Territorial Cohesion
01/01/2023	DGCCRF (Direction générale dela concurrence, de la consommation et de la répression des fraudes) published news (Consumption: what will change in 2023) on the changes related to AGEC Law and consumer products for 2023.
10/02/2023	Ministry of Ecological Transition and Territorial Cohesion published news: Three years of the anti-waste law for a circular economy: transformations in progress and to come. This news piece explains 10 measures already imposed by the anti-waste law already and 10 measures that will soon be put in place to continue the fight against all forms of waste in our daily lives.
08/02/2023	The Ministry of Ecological Transition and Territorial Cohesion website related to the anti-waste law for a circular economy has been updated.
17/01/2023	The Ministry of Ecological Transition and Territorial Cohesion published a document on plastics. This document provides information and questions and answers about plastic material in general and related to packaging.

Italy

Plastic tax deferred

On 1^st January 2023, Italy’s plastic tax was due to enter into force, but the budget law for 2023 has deferred the of plastic tax to January 2024.

This tax is implemented by the Law no. 160/2019 (Article 1, paragraphs 634 – 658), which sets the obligation to submit a declaration and pay the tax to the Italian customs and monopolies agency at quarterly intervals. It also outlines, subjective and objective requirements, the scope of application, and penalties applicable.

The plastic tax is intended as a measure to discourage the consumption of single-use plastic products called “MACSI” (manufatti in plastica con singolo impiego).

The tax is €0.45 per kilogram of virgin plastic contained. The tax does not apply to plastic material obtained from recycling processes, medical devices, or those used to store and protect medical items. Compostable plastic in accordance with DIN EN 13432 is also excluded. Declaring and paying the plastic tax is mandatory. For non-resident entities in Italy, it is necessary to appoint a tax representative in Italy.

New CONAI's guidelines for the environmental labelling of packaging

On 13^th January 2023, the Italian National Packaging Consortium (CONAI) published a full series of specific guidelines for product packaging for different sectors. The guidelines are:

CPSC Issues NPR for Safety Standard for Button Cell or Coin Batteries

On August 16^th, 2022, the United States enacted Public Law 117-171, also known as “Reese’s Law,” to require the Consumer Product Safety Commission (CPSC) to establish a final consumer product safety standard for button cell or coin batteries and consumer products containing button cell or coin batteries, no later than 1 year after the Act’s enactment.

As required by the Reese’s Law, on February 9^th, 2023, the US Consumer Product Safety Commission (CPSC) issued a Notice of Proposed Rulemaking for the Safety Standard and Notification Requirements for Button Cell or Coin Batteries and Consumer Products Containing Such Batteries (16 CFR 1263). The new proposed rule will establish performance requirements for battery compartments on consumer products that contain, or are designed to use, one or more button cell or coin batteries, in order to eliminate or adequately reduce the risk of injury from ingestion of button cell or coin batteries by children 6 years old and younger. The proposed rule also requires warning labels on the packaging, battery compartments, and accompanying instructions and manuals of consumer products containing button cell or coin batteries.

Any toy products that are in compliance with the battery accessibility and labeling requirements of 16 CFR 1250, Safety Standard Mandating ASTM F963 for Toys, are exempt under the rule. Zinc-air button cell or coin batteries that do not present an ingestion risk as determined by the CPSC are also exempt under the rule.

If the rule is finalized, consumer products subject to the rule must be tested and certified as compliant with the rule. The CPSC is accepting comments until March 13^th, 2023.

Button cell or coin battery is defined as:

A single cell battery with a diameter greater than the height of the battery; or
Any other battery, regardless of the technology used to product an electrical charge, that is determined by the Commission to pose an ingestion hazard.

Consumer product containing button cell or coin batteries is defined as a consumer product containing or designed to use one or more button cell or coin batteries, regardless of whether such batteries are intended to be replaced by the consumer or are included with the product or sold separately.

Hong Kong

Hong Kong Amends Children’s Product Standards

On February 17^th, 2023, Hong Kong’s Secretary for Commerce and Economic Development issued Toys and Children’s Products Safety Ordinance (Amendment of Schedule 2) Notice 2023 to amend 4 product standards for demonstrating compliance with the Toys and Children’s Products Safety Ordinance. The new standards will become effective on August 1^st, 2023. Please see Table 1 below for the list of new standards.

Table 1:

Category	Current Standard	New Standard
Bunk beds for domestic use	ASTM F1427-21	ASTM F1427-21 ed. 1
Child safety barriers for domestic use	ASTM F1004-19	ASTM F1004-21
Children’s highchairs and multi-purpose highchairs for domestic use	ASTM F404-20	ASTM F404-21
Wheeled child conveyances	ASTM F833-19	ASTM F833-21

Taiwan

Taiwan Amends Hygienic Standards for Food Utensils, Containers and Packages

The Taiwan Food and Drug Administration has recently published Notification Order 1111303439 to amend the Hygienic Standards for Food Utensils, Containers and Packages. The amendment includes the following revisions:

Amending the name of the source of law
Amending the text of the management regulations on the prohibition of recycling of plastic containers, and strengthen the scope of application
Replacing the table for test items of various materials to a new table
Adding specifications for material testing and dissolution testing items for alloy materials

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PPE

Europe

Changes to product safety standards

On 9^th December 2022, the European Commission published Decision 2022/2414 which amends the Implementing Decision (EU) 2020/668 in relation to harmonised standards on requirements, testing and marking of particle filters for respiratory protective devices, general requirements for protective clothing, requirements for eye protectors for squash and eye protectors for racquetball and squash 57, and requirements and test methods for footwear protecting against risks in foundries and during welding and associated processes.

Below is a table summarising the rows which have been added to the Annexes to Implementing Decision (EU) 2020/668:

Added standards in Annex I
Row	Reference	Title
39.	EN 143:2021	Respiratory protective devices – Particle filters – Requirements, testing, marking
40.	EN ISO 13688:201	Protective clothing – General requirements (ISO 13688:2013) EN ISO 13688:2013/A1:2021
41.	EN ISO 18527-2:2021	Eye and face protection for sports use – Part 2: Requirements for eye protectors for squash and eye protectors for racquetball and squash 57 (ISO 18527-2:2021)
42.	EN ISO 20349-1:201	Personal protective equipment – Footwear protecting against risks in foundries and welding – Part 1: Requirements and test methods for protection against risks in foundries (ISO 20349-1:2017) EN ISO 20349-1:2017/A1:2020
43.	EN ISO 20349-2:2017	Personal protective equipment – Footwear protecting against risks in foundries and welding – Part 2: Requirements and test methods for protection against risks in welding and allied processes (ISO 20349-2:2017) EN ISO 20349-2:2017/A1:2020’
Added standards in Annex II
Row	Reference	Title	Date of withdrawal
30.	EN 143:2000	Respiratory protective devices – Particle filters – Requirements, testing, marking EN 143:2000/AC:2005 EN 143:2000/A1:2006	9 June 2024
31.	EN ISO 13688:2013	Protective clothing – General requirements (ISO 13688:2013)	9 June 2024
30.	EN 143:2000	Respiratory protective devices – Particle filters – Requirements, testing, marking EN 143:2000/AC:2005 EN 143:2000/A1:2006	9 June 2024

This table summarises the rows which have been replaced in the Annex II to Implementing Decision (EU) 2020/668:

Replaced standards in Annex II
Row	Reference	Title	Date of withdrawal
22.	EN 352-1:2002	Hearing protectors – General requirements – Part 1: Ear-Muffs	21 July 2024
23.	EN 352-2:2002	Hearing protectors – General requirements – Part 2: Ear-plugs	21 July 2024
24.	EN 352-3:2002	Hearing protectors – General requirements – Part 3: Ear-muffs attached to an industrial safety helmet	21 July 2024
25.	EN 352-4:2001	Hearing protectors – Safety requirements and testing – Part 4: Level-dependent ear-muffs EN 352-4:2001/A1:2005	21 July 2024
26.	EN 352-5:2002	Hearing protectors – Safety requirements and testing – Part 5: Active noise reduction ear-muffs EN 352-5:2002/A1:2005	21 July 2024
27.	EN 352-6:2002	Hearing protectors – Safety requirements and testing – Part 6: Ear-muffs with electrical audio input	21 July 2024
28.	EN 352-7:2002	Hearing protectors – Safety requirements and testing – Part 7: Level-dependent ear-plugs	21 July 2024
29.	EN 352-8:2008	Hearing protectors – Safety requirements and testing – Part 8: Entertainment audio ear-muffs	21 July 2024

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