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Media Centre >> News >> Regulatory updates 02-2024

Consumer Products | Monthly bulletin | February 2024

Chemical | Cosmetics & Personal Care | Softlines & Leather |
Toys, Childcare & Hardlines | Personal Protective Equipment

Chemical

Europe

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

On 23^rd January 2024, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs. With the addition of five new substances, the current list of SVHCs now contains 240 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	2,4,6-tri-tert-butylphenol	211-989-5	732-26-3	Toxic for reproduction (Article 57c) Persistent, bioaccumulative and toxic (PBT) (Article 57d)	Manufacture of another substance; formulation of mixtures and in fuel products.
2	2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol	221-573-5	3147-75-9	Very persistent and very bioaccumulative (vPvB) (Article 57e)	Air care products, coating products, adhesives and sealants, lubricants and greases, polishes and waxes and washing and cleaning products.
3	2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one	438-340-0	119344-86-4	Toxic for reproduction (Article 57c)	Inks and toners, coating products.
4	Bumetrizole	223-445-4	3896-11-5	vPvB (Article 57e)	Coating products, adhesives and sealants and washing and cleaning products.
5	Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol	700-960-7	-	vPvB (Article 57e)	Adhesives and sealants, coating products, fillers, putties, plasters, modelling clay, inks and toners and polymers.

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 must 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, must 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.

Dibutyl phthalate entry update on the SVHCs list of REACH

On 23^rd January 2024, the ECHA (European Chemicals Agency) updated the existing Candidate List of SVHCs for dibutyl phthalate entry. Its endocrine disrupting properties for the environment are included.

See below a table indicating the update for dibutyl phthalate entry:

Nº

Substance name

EC number

CAS number

Reason for inclusion

Examples of use(s)

Dibutyl phthalate

(updated entry)

201-557-4

84-74-2

Endocrine disrupting properties
(Article 57(f) - environment)

Metal working fluids, washing and cleaning products, laboratory chemicals and polymers.

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 must 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, must 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.

Nickel standards update under REACH

On 20^th December 2023, the European Commission published a Commission communicatione related to entry 27 (nickel) of Annex XVII to REACH which lists the titles and references of European standards under this entry. The updated list of standards are as follows:

ESO	Reference and title of the standard	Reference of superseded standard
CEN	EN 1811:2023 Reference test method for release of nickel from all post assemblies which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin.	EN 1811:2011+A1:2015
CEN	EN 12472:2020 Method for the simulation of accelerated wear and corrosion for the detection of nickel release from coated items.	EN 12472:2005+A1:2009
CEN	EN 16128:2015 Ophthalmic optics – Reference method for the testing of spectacle frames and sunglasses for nickel release.	EN 16128:2011

New proposal for chemicals strategy

On 7^th December 2023, the following three legislative proposals related to chemicals strategy for sustainability were adopted:

The proposals aim to:

Strengthen cooperation and consolidate scientific and technical work on chemicals in the European Chemicals Agency, the European Food Safety Authority, the European Environment Agency and the European Medicines Agency.
Establish a Common Data Platform and introduce a ‘one-stop shop' access to data on chemicals held by the EU agencies and the Commission, compiled under EU legislation.
Establish systematic collection of human biomonitoring data generated in the EU to inform policy makers about the levels of chemicals found in people. This will help to better estimate the level of exposure of EU citizens to chemicals.
Set up a monitoring and outlook framework to enable early detection of chemical risks to prevent the pollution from becoming widespread.
Empower the European Chemicals Agency to generate data when needed.
Ensure transparency of scientific studies on chemicals, including those commissioned by companies.

The three proposals will now be examined by the European Parliament and the Council under the ordinary legislative procedure.

Recent publications on 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
17/01/2024	ECHA may launch consultations or calls for comments and evidence in relation to aromatic brominated flame retardants by European commission request. The ECHA’s report will support the Commission in deciding whether to request ECHA to prepare a restriction dossier. The ECHA’s report is expected to be ready by the end of December 2024.	For more information, consult the ECHA’s website here.
17/01/2024	ECHA has published a screening report to assess whether the use of four benzotriazoles in articles should be restricted in accordance with REACH Article 69.	For more information , consult the ECHA’s website here.
17/01/2024	Update of Guidance on Information Requirements and Chemical Safety Assessment. The guidance are: Endpoint specific guidance (Chapter R.7b) Endpoint specific guidance (Chapter R.7c) PBT Assessment (Chapter R.11)	For more information , consult the ECHA’s website here.
17/01/2024	ECHA has published a list of examples illustrating weight of evidence assessment. The examples are from the Candidate List of substances of very high concern that were identified as PBT/vPvB (very persistent, very bioaccumulative). The list will be periodically updated.	For more information , consult the ECHA’s website here.

Other interesting links about REACH from the ECHA’s website

Recent publications regarding CLP Regulation

The following table provides a non-exhaustive summary of some recent updates regarding CLP Regulation (EC) No 1272/2008:

Summary of the most recent updates
Date	Subject	Link
07/12/2023	ECHA has updated the Guidance on the Application of the CLP Criteria.	For more information consult, ECHA’s website here.
19/12/2023	Proposal for a revision of the Regulation on classification, labelling and packaging of chemicals (CLP) has been published by the European Commission. The European Parliament and the Council will now formally adopt the new Regulation	For more information, consult the official publication here.
05/01/2024	The European Commission published the Commission Delegated Regulation (EU) 2024/197 of 19 October 2023 amending Regulation (EC) No 1272/2008 as regards the harmonised classification and labelling of certain substances. It contains several changes to Table 3 in Part 3 of Annex VI to Regulation (EC) No 1272/2008 which consists of the addition of 28 new substances and replacement of 24 entries. It shall apply from 1^st September 2025.	For more information, consult the official publication here.

Interesting links about CLP on the ECHA’s website

Türkiye

New deadlines for substances manufactured in or imported into Turkey

On 23^rd December 2023, an amendment of KKDIK (Türkiye REACH) was published. It modifies the Türkiye KKDIK Registration deadline for substances manufactured in or imported into Türkiye. The new deadlines are:

Deadline	Quantity of substances
31.12.2026	Substances at ≥1 000 t/a Substances classified as Aquatic Acute 1 and Aquatic Chronic 1 (H400, H410) at ≥100 t/a CMR substances (Category 1A and 1B) at ≥1 t/a
31.12.2028	Substances at 100 – 1 000 t/a.
31.12.2030	Substances at 1 - 100 t/a

For more information, consult the official publication in Turkish Official Gazette here (only in Turkish language).

CLP Regulation 2023 publication

On 19^th December 2023, the Secretary of State published the Statutory guidance related to the Classification, Labelling and Packaging of Substances and Mixtures (Amendment and Consequential Provision) Regulations 2023 (S.I. No 1344).

This instrument makes consequential amendments to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on Classification, Labelling and Packaging of Substances and Mixtures (“the GB CLP Regulation”), to remove any mention of Annex VIII following the revocation of Annex VIII of the GB CLP Regulation by the Retained EU Law (Revocation and Reform) Act 2023 (“the 2023 Act”).

California adds BPS to proposition list of chemicals

Effective December 29, 2023, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced the addition of Bisphenol S (BPS) (CAS No. 80-09-1) to the list of chemicals known to the State of California to cause reproductive toxicity under Proposition 65. Products containing BPS will require a Proposition 65 warning starting December 29, 2024.

Source:

Bisphenol S (BPS) Added to Proposition 65 List Following 2023 Meeting of the Developmental and Reproductive Toxicant Identification Committee - OEHHA

Sustainability, circular economy and environment

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

The table below summarises the most recent publications regarding the environment, circular economy, and sustainability (non-exhaustive):

Entity

Date

Publication

European Commission

15/12/2023

Amendments adopted by the European Parliament on 11^th May 2023 on the proposal for a directive of the European Parliament and of the Council on amending Directives 2005/29/EC and 2011/83/EU as regards empowering consumers for the green transition through better protection against unfair practices and better information (COM(2022)0143 — C9-0128/2022 — 2022/0092(COD))

It contains a total of 84 amendments which will affect the Directive 2011/83/EU and the Directive 2005/29/EC.

European
Commission

26/01/2024

8th Environment Action Programme – Mid-term Review

The 8th Environment Action Programme sets out the EU’s priority objectives for environment and climate policy until 2030 and its long-term vision to 2050 of living well, within planetary boundaries. The present initiative will assess the progress achieved in attaining the programme’s 2030 priority objectives and 2050 vision, as well as the progress made in establishing a robust monitoring framework capable of assessing systemic change.

French Ministry of Ecological Transition

December 2023

According to the principle of extended producer responsibility (EPR), waste management must be ensured by the producers of said products. To fulfill their obligations, they must join an approved eco-organisation or set up an approved individual system. The following texts indicate approved eco-organizations for different products categories.

Date	Approved eco-organisation orders
28/12/2023	Order of December 21, 2023 approving an eco-organization in the extended responsibility sector of the producer of DIY and garden items Valobat is approved until the 31^st of December 2027.
30/12/2023	Order of December 21, 2023 approving an eco-organisation in the extended responsibility sector of producers of furnishing elements VALDELIA is approved until the 31^st of December, 2029.
30/12/2023	Order of December 21, 2023 approving an eco-organisation in the extended responsibility sector of producers of furnishing elements VALOBAT is approved until the 31^st of December, 2029.
29-12-2023	Order of December 27, 2023 approving an eco-organisation in the extended responsibility sector of producers of furniture elements in application of article L. 541-10 of the environmental code ECOMAISON is approved until the 31^st of December, 2029.
29/12/2023	Order of December 27, 2023 approving an eco-organisation in the extended responsibility sector of the producer of packaging, printed paper and paper for graphic use whose final holders produce household and similar waste in application of the article L. 541-10 of the environmental code CITEO is approved from the 1^st of January to the 31^st of December 2024.
29/12/2023	Order of December 27, 2023 approving an eco-organisation in the extended responsibility sector of the producer of packaging, printed paper and paper for graphic use whose final holders produce household and similar waste in application of the article L. 541-10 of the environmental code ADELPHE is approved from the 1^st of January to the 31^st of December 2024.
29/12/2023	Order of December 27, 2023 approving an eco-organisation in the extended responsibility sector of the producer of packaging, printed paper and paper for graphic use whose final holders produce household and similar waste in application of the article L. 541-10 of the environmental code LEKO is approved from the 1^st of January to the 31^st of December 2024.

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Cosmetics & Personal Care

Sun protection testing: Eurofins, an ally in current and future regulations

Exposure to ultraviolet solar radiation is the main environmental source of damage to human skin. Protecting consumers from exposure to the sun's UVB and UVA rays is therefore an important issue.

In recent years, in vivo test methods have been developed to measure the extent of protection against solar UV radiation. However, for SPF determination, the development of alternative methods to in vivo testing is ongoing.

Alternative techniques are being analyzed as part of the "Alt-SPF" program run by a consortium of cosmetics firms and CROs, including Eurofins Cosmetics and Personal Care.

Further meetings of this consortium and the ISO committee are expected to lead to the registration of two of these methods (late 2024 and/or early 2025):

“Double plate in-vitro" under ISO reference DIS 23675
HDRS under ISO DIS 23698.

Initially, these methods will only be valid for SPF static. Stress tests (resistance to water, sweat, etc.) will not be included in the scope of these standards, and will be added later.

At present, for the determination of SPF static and a fortiori for tests with water resistance, the official methods remain SPF ISO24444:2019 and the FDA 2011 monograph.

However, SPF static screening tests can be carried out using the "double plate" method on conventional emulsions.

Changes are also expected in FDA methods, and it's worth keeping abreast of the current and future regulatory environment for solar testing (e.g. in South Korea).

With a team of experts actively involved in standardization on committees (e.g., the ALT-SPF Consortium, Members of ISO etc.), Eurofins is committed to staying abreast of the current and future regulatory solar testing environment.

At the crossroads of beauty and food: Testing the efficacy of nutraceuticals with Eurofins

From improving the appearance of skin, hair and nails to enhancing well-being, nutraceuticals are booming.

Claims for nutraceuticals can be very similar to those for cosmetics, but as they come in the form of tablets, gummies or ingestible drinks, they must comply with food regulations rather than cosmetics.

For example, in Europe, nutritional and health claims on foodstuffs, including food supplements, are subject to a centralised scientific assessment by the European Food Safety Authority (EFSA).

Eurofins is here to help you analyze the effectiveness of nutraceuticals on skin structure, hair quality and well-being:

Anti-ageing
Anti-dark circles
Moisturizing
Firming
Slimness
Anti-stress
Anti-sleeping troubles
Painkiller
Microbiome
Digestive health

These clinical approaches can be combined with a global approach to ensure safe and effective products: with regulatory and toxicological support or physicochemical analysis.

Hair loss: a must-have nutraceutical

Eurofins Cosmetics & Personal Care has observed that all active ingredient complexes tested differed significantly from the placebos. Interestingly, subjects with a higher baseline anagen (hair growth phase) rate achieved a higher anagen rate during the observation period. Considering the temporal development, the anagen rate increases from measurement time to measurement time and shows the greatest increase at the last measurement time point. However, the first positive results can be expected after three months at the earliest, whereby often only a tendency but no significance is achieved.

For the determination of hair loss, it is important to use a valid method with high acceptance by the panelists. In this context, the TrichoScale® is a validated and non-invasive tool to objectively quantify the effectiveness of a hair loss treatment in nutritional supplement studies.

Eurofins C&PC teams are used to conducting studies on health and beauty supplements. We can help you with regulatory submissions and advise you on the most appropriate approaches to meet your expectations.

Biodegradation of microplastics: Eurofins strengthens its worldwide expertise

Microplastics are everywhere on the planet. These small, solid plastic particles, made up of blends of polymers and functional additives, are more resistant to degradation. They can be formed unintentionally or deliberately, and added to products for specific purposes, which can be harmful to ecosystems and human health. It is therefore imperative to control their pollution.

In September 2023, the European Commission published Regulation (EU) no. 2023/2055 to restrict the use of microplastics on the European market. This regulation prohibits the intentional addition of synthetic polymer microparticles (microplastics) in consumer products at a concentration >0.01% (by mass).

However, exemptions have been provided, particularly, for degradable polymers according to requirements of Appendix 15. The evidence for exclusion must be made available to the authorities on request, this includes OECD test method (TG 301/ TG 310) for Ready Biodegradability. These tests determine the potential for a substance to undergo ready biodegradation under aerobic conditions, mimicking the conditions found in sewage treatment plants. The CO₂ evolution is measured regularly over the test period indicating that the polymer is degraded. The substance is considered "Readily Biodegradable" if it meets the criteria within the specified timeframe.

However, there are numerous cases where it is necessary to analyze non-biodegradable microplastics when they are added internationally to consumer products. Over the past six years, Eurofins has strategically invested in establishing a network of five laboratories (located in Norway, Hungary, Spain, the USA, and Australia), exclusively dedicated to implementing cutting-edge microplastics testing. Our laboratories are equipped with a comprehensive range of analytical techniques, including spectroscopy (Raman, FTIR, LDIR) and thermal analysis (TD-GC/MS, PYR-GC/MS), each possessing unique capabilities for the identification, quantification, sizing, and characterisation of microplastics.

While our primary focus has traditionally been on analyzing environmental matrices, in recent years, our laboratories have progressively expanded their scope to include the analysis of consumer products such as food packaging, coffee cups, teabags, as well as cosmetics and personal care products such as creams, exfoliants and shower gels. Notably, two of our laboratories have earned recognition by receiving ISO/IEC 17025 (2017) accreditation for Microplastics testing, affirming the high standards of quality and reliability in our analytical processes.

Our sales team is here to help you make decisions about the materials you use and take preventive measures against microplastic pollution, by assessing and validating the use of recycled content and providing biodegradability and disintegration tests.

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Softlines & Leather

Europe

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

On 23^rd January 2024, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs. With the addition of five new substances, the current list of SVHCs now contains 240 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	2,4,6-tri-tert-butylphenol	211-989-5	732-26-3	Toxic for reproduction (Article 57c) Persistent, bioaccumulative and toxic (PBT) (Article 57d)	Manufacture of another substance; formulation of mixtures and in fuel products.
2	2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol	221-573-5	3147-75-9	Very persistent and very bioaccumulative (vPvB) (Article 57e)	Air care products, coating products, adhesives and sealants, lubricants and greases, polishes and waxes and washing and cleaning products.
3	2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one	438-340-0	119344-86-4	Toxic for reproduction (Article 57c)	Inks and toners, coating products.
4	Bumetrizole	223-445-4	3896-11-5	vPvB (Article 57e)	Coating products, adhesives and sealants and washing and cleaning products.
5	Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol	700-960-7	-	vPvB (Article 57e)	Adhesives and sealants, coating products, fillers, putties, plasters, modelling clay, inks and toners and polymers.

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 must 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, must 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 resolution for a sustainable and circular textile sector

On 21^st December 2023, the European Commission published the EU Strategy for Sustainable and Circular Textiles.

This resolution indicates the EU strategy for establishing a sustainable textile. The main aim is to have textiles products that are durable, reusable, repairable, recyclable, made to a great extent of recycled fibres, and free of hazardous substances. It also underlines that textile products should be produced in a way that respects human and social rights, the environment and animal welfare.

This resolution calls on the Commission and the Member States to adopt measures to put an end to fast fashion, as the current levels of production and consumption are unsustainable.

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

European initiatives related to textile labelling rules

The European Commission published a new initiative related to EU textile labelling rules.

Below is a summary table with the published initiative:

Published initiative

Status

Textile labelling rules (revision)

This initiative revises European textile labelling. Its principle aims are to:

ensure accurate, intelligible and comparable information to consumers, notably on environmentally relevant aspects
reduce compliance costs
ensure regulatory clarity and consistency.

by introducing comprehensive requirements on the physical and digital labelling of textiles and related products.

Consultation period

19^th December 2023 – 15^th April 2024

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Toys, Childcare & Hardlines

Europe

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

On 23^rd January 2024, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs. With the addition of five new substances, the current list of SVHCs now contains 240 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	2,4,6-tri-tert-butylphenol	211-989-5	732-26-3	Toxic for reproduction (Article 57c) Persistent, bioaccumulative and toxic (PBT) (Article 57d)	Manufacture of another substance; formulation of mixtures and in fuel products.
2	2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol	221-573-5	3147-75-9	Very persistent and very bioaccumulative (vPvB) (Article 57e)	Air care products, coating products, adhesives and sealants, lubricants and greases, polishes and waxes and washing and cleaning products.
3	2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one	438-340-0	119344-86-4	Toxic for reproduction (Article 57c)	Inks and toners, coating products.
4	Bumetrizole	223-445-4	3896-11-5	vPvB (Article 57e)	Coating products, adhesives and sealants and washing and cleaning products.
5	Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol	700-960-7	-	vPvB (Article 57e)	Adhesives and sealants, coating products, fillers, putties, plasters, modelling clay, inks and toners and polymers.

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 must 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, must 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.

Dibutyl phthalate entry update on the SVHCs list of REACH

See below a table indicating the update for dibutyl phthalate entry:

Nº

Substance name

EC number

CAS number

Reason for inclusion

Examples of use(s)

Dibutyl phthalate

(updated entry)

201-557-4

84-74-2

Endocrine disrupting properties
(Article 57(f) - environment)

Metal working fluids, washing and cleaning products, laboratory chemicals and polymers.

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 must 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, must 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.

Update on the European Commission’s toys guidance

In December 2023, the European Commission published two publications related to safety on toys.

One of them is the European Guidance document Nº 7 on the application of directive 2009/48/EC on the safety of toys and other products used in or on the water. This document has been revised to help on the classification, deciding if a product is a toy or not.

The other publication is notes from market surveillance authorities related to small magnetic balls and magnetic building kits. The main point is that small magnetic balls and magnetic building kits must comply with the general safety requirement in Article 10 (2) of the Toy Safety Directive to be sold in the EU market. If the toy does not comply, immediate action shall be taken by the market surveillance authorities of a Member State to bring the toy into compliance with those requirements, to withdraw the toy from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.

Standard updates

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

(*) Date of withdrawal: 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 15372:2023	Furniture - Strength, durability and safety - Requirements for non-domestic tables	2024-06-30	EN 15372:2016
EN 17850:2023	Hardware for furniture - Star bases for seating - Requirements and test methods	2024-06-30
EN 1273:2020+ A1:2023	Child care articles - Baby walking frames - Safety requirements and test methods	2024-06-30	EN 1273:2020 /FprA1 EN 1273:2020
EN 15185:2023	Furniture - Assessment of the surface resistance to abrasion	2024-06-30	EN 15185:2011
EN 17428:2023	Packaging - Determination of the degree of disintegration under simulated home composting conditions	2024-06-30

France

New packaging requirements for intimate protection products

On 31^st December 2023, the French authorities published Decree No. 2023-1427 of December 30, 2023 relating to information on certain intimate protection products. The main points are the definition of this type of products and the information that must appear on the packaging or instructions for intimate protection products such as absorbent towels, panty liners, menstrual panties, tampons, menstrual cups, menstrual sponges, as well as the terms according to which they are brought to the attention of the consumer. These provisions do not apply to medical devices defined by the aforementioned regulation of April 5, 2017.

The provisions of the decree come into force on 1^st April 2024.

For more information, consult the official publication in the Legifrance website here.

Relevant publication related to ERP and AGEC Law

Date	Publication
28/12/2023	Order of December 21, 2023 approving an eco-organization in the extended responsibility sector of the producer of DIY and garden items. Valobat is approved until the 31^st of December 2027.
30/12/2023	Order of December 21, 2023 approving an eco-organization in the extended responsibility sector of producers of furnishing elements. VALDELIA is approved until the 31^st of December 2029.
30/12/2023	Order of December 21, 2023 approving an eco-organization in the extended responsibility sector of producers of furnishing elements. VALOBAT is approved until the 31^st of December 2029.
29-12-2023	Order of December 27, 2023 approving an eco-organization in the extended responsibility sector of producers of furniture elements in application of article L. 541-10 of the environmental code. ECOMAISON is approved until the 31^st of December 2029.
29/12/2023	Order of December 27, 2023 approving an eco-organization in the extended responsibility sector of the producer of packaging, printed paper and paper for graphic use whose final holders produce household and similar waste in application of the article L. 541-10 of the environmental code. CITEO is approved from the 1^st of January to the 31^st of December 2024.
29/12/2023	Order of December 27, 2023 approving an eco-organization in the extended responsibility sector of the producer of packaging, printed paper and paper for graphic use whose final holders produce household and similar waste in application of the article L. 541-10 of the environmental code. ADELPHE is approved from the 1^st of January to the 31^st of December 2024.
29/12/2023	Order of December 27, 2023 approving an eco-organization in the extended responsibility sector of the producer of packaging, printed paper and paper for graphic use whose final holders produce household and similar waste in application of the article L. 541-10 of the environmental code. LEKO is approved from the 1^st of January to the 31^st of December 2024.

Technical publications

The latest publications by Directorate General for Competition, Consumer Affairs and Fraud Prevention (DGCCRF) related to consumer products and toys:

DGCCRF sheet – Management of alerts concerning toys.
DGCCRF investigation report – How the DGCCRF ensures the safety of toys.
DGCCRF sheet – Essential oils.
DGCCRF sheet - Beware of unfair clauses on online marketplaces.
DGCCRF sheet – Bulk sales: consumers, what to watch out for?
DGCCRF sheet - Bulk sales: professionals, what are the regulations?

Switzerland

Harmonisation of the national law with European legislation for food contact materials

On 8^th December 2023, Switzerland published the Official Collection 2023 836 (German, French and Italian versions) to revise the Ordinance on Materials and Articles Intended to Come into Contact with Foodstuffs (817.023.21).

The main point is to harmonize the nation’s law on food contact materials (FCM) and articles with those in the European Union.

It mainly incorporates provisions from:

Regulation (EU) 2020/1245 on food contact plastics.
It adopts Directive 84/500/EEC for materials and articles made of ceramic, glass, enamel, or other similar materials.
It establishes a declaration of conformity (DoC) for packaging inks.

between other amendments and requirements.

Türkiye

New statement on control of imports for toys and consumer products

On 31^st December 2023, Turkey’s Ministry of Commerce published three communications which establish the nation’s import control requirements for toys and some consumer products. They became effective on 1^st January 2024. Below is a summary containing information on these new communications:

Communiqué on Import Control of Toys (Product Safety and Inspection: 2024/10)
Communiqué on Import Control of Consumer Products (Product Safety and Inspection: 2024/12). The consumer products which are included in this Communiqué are:
- Cufflinks and similar items
- Imitation jewelry
- Mobile phone and computer cases
- Mobile phone and computer tablet covers and screen protection films.
- Mouse pads
- Plastic gloves for domestic use
- Stationery items (except toys)
- Watches and straps
Communiqué on Import Control of Maternity and Baby Products (Product Safety and Inspection: 2024/17). Below is a non-exhaustive list of the scope of this Communique:
- Toilet seats for children
- Teethers
- Products falling under the scope of the following standards:
- TS EN 1273 ‘Baby walking frames’
- TS EN 1400+A2 ‘Soothers for babies and young children’
- TS EN 1466 ‘Carry cots and stands for domestic use’
- TS EN 13138-3 ‘Buoyant aids for swimming instruction’
- TS EN 14350+A1 ‘Drinking equipment intended for young children’
- TS EN 14988+A1 ‘Children’s highchairs’
- Certain products which are inspected for compliance with the Turkish Food Codex Regulation on Substances and Materials in Contact with Food (KODEKS).

In general, they require those products to comply with a list documents, test reports, specified chemical restrictions under Turkey’s REACH (Kimyasalların Kaydı, Değerlendirilmesi, İzni Ve Kısıtlanması Hakkında Yönetmelik (KKDIK)), other pieces of legislation and/or standards to be upload to TAREKS.

CPSC approves revised ASTM F963-23 as a mandatory toy standard

On January 18, 2024, the U.S. Consumer Product Safety Commission (CPSC) published in the Federal Register a direct final rule to approve the revised ASTM F963-23 as the mandatory toy safety standard. The direct final rule incorporates by reference ASTM F963-23 and updates the existing notice of requirements (NOR) that provide the criteria and process for the CPSC’s acceptance of accreditation of third-party conformity assessment bodies for testing toys to ASTM F963-23.

Technical requirements for the following toy safety requirements were revised:

Battery-operated toys
Expanding materials
Sound producing toys (acoustics)
Projectile toys

The standard was also revised to align with the CPSC requirements for phthalate content, heavy elements (metals) – toy substrate material exemptions, and CPSIA Section 103 tracking labels for children’s products.

The rule is effective from April 20, 2024, unless the CPSC receives a significant adverse comment by February 20, 2024. Toys manufactured on and after April 20, 2024 will require testing to ASTM F963-23 at a CPSC accepted third-party lab for certification.

Source:

Direct final rule: 2024-00741.pdf (govinfo.gov)

Standards updates

See below a table summarising some recent ASTM standards updates:

Reference	Title
ASTM F2417	Standard Specification for Fire Safety for Candles

Canada

Canada updates standards under the glazed ceramics and glassware regulations

Canada recently published the Regulations Amending Certain Department of Health Regulations (Miscellaneous Program): SOR/2023-247 in the Canada Gazette to update two test methods for demonstrating compliance with the migratable limits for lead and cadmium under the Glazed Ceramics and Glassware Regulations (SOR/2016-175).

Please see Table 1 for a summary of the updated test methods:

Section of Schedule	Standard	Effective Date
1	ISO 6486-1:2019, entitled Ceramic ware, glass ceramic ware and glass dinnerware in contact with food — Release of lead and cadmium — Part 1: Test Method, third edition, August 2019	24th November 2023
2	ASTM C927-80 (2019)e1, entitled Standard Test Method for Lead and Cadmium Extracted from the Lip and Rim Area of Glass Tumblers Externally Decorated with Ceramic Glass Enamels	24th November 2023

International

Regulatory proposals notified to WTO

The table below summarises the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):

Notification number	Countries	Title
G/TBT/N/BRA/1518	Brazil	Ordinance No. 579, 5 December 2023 Amends Ordinance No. 5 December 2023 establishes the risk classification of economic activities associated with acts of release under the responsibility of Inmetro within the scope of the Compulsory Conformity Assessment. It revokes provisions to the contrary Ordinance No. 75, 4 February 2021, which approves the Technical Regulation for the Quality of Spring Mattresses and the Conformity Assessment Requirements for Spring Mattresses -Consolidated. It also revokes No. 35 5 February 2021 which approves the Technical Regulation for Quality and the Assessment Requirements of Compliance for Flexible Polyurethane Foam Mattresses and Mattresses -Consolidated.
G/TBT/N/ISR/1304	Israel	SI 1003 part 1.2 -Release of lead and cadmium from ware in contact with food: Ceramic ware, glass-ceramic ware and glass dinnerware -Permissible limits. First amendment to the Mandatory Standard SI 1003 part 1.2. This amendment changes the labelling requirements based on Article 15 –Labelling of the European Regulation EC 1935/2004. Relevant documents: Israel Mandatory Standard SI 1003 part 1.2 (August 2022); International Standards ISO 6486 -2-Second edition:1999-12-15. European Regulation EC 1935/2004.
G/TBT/N/ISR/1305	Israel	SI 1003 part 3.2 -Release of lead and cadmium from ware in contact with food: Glass hollowware -Permissible limits. Second amendment to the Mandatory Standard SI 1003 part 3.2. This amendment changes the labelling requirements and is based on Article 15, Labelling, of the European Regulation EC 1935/2004. Relevant documents: Israel Mandatory Standard SI 1003 part 3.2 (June 2013) and Amendment 1 (March 2019). International Standards ISO 7086-2 -Second edition: 2000-03-01. European Regulation EC 1935/2004.
G/TBT/N/ISR/1306	Israel	SI 562 part 3 -Safety of toys: Migration of certain chemical elements Revision of the Mandatory Standard SI 562 part 3, dealing with the migration of certain chemical elements from toys. This draft standard revision adopts the European Standard EN-71-3: 2019 + A1: April 2021, with a few changes that appear in the standard's Hebrew section. Both the old standard and this new revised standard will apply from entry into force of this revision for 12 months. During this time, products may be tested according to the old or the new revised standard. Relevant documents: Israel Mandatory Standard SI 562 part 3 (October 2022); European Standard EN-71-3: 2019 + A1: April 2021.

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Personal Protective Equipment

Europe

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

On 23^rd January 2024, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs. With the addition of five new substances, the current list of SVHCs now contains 240 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	2,4,6-tri-tert-butylphenol	211-989-5	732-26-3	Toxic for reproduction (Article 57c) Persistent, bioaccumulative and toxic (PBT) (Article 57d)	Manufacture of another substance; formulation of mixtures and in fuel products.
2	2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol	221-573-5	3147-75-9	Very persistent and very bioaccumulative (vPvB) (Article 57e)	Air care products, coating products, adhesives and sealants, lubricants and greases, polishes and waxes and washing and cleaning products.
3	2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one	438-340-0	119344-86-4	Toxic for reproduction (Article 57c)	Inks and toners, coating products.
4	Bumetrizole	223-445-4	3896-11-5	vPvB (Article 57e)	Coating products, adhesives and sealants and washing and cleaning products.
5	Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol	700-960-7	-	vPvB (Article 57e)	Adhesives and sealants, coating products, fillers, putties, plasters, modelling clay, inks and toners and polymers.

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 must 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, must 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.

Changes to product safety standards

On 11^th December 2023, the European Commission published Decision 2023/2752 which amends the Implementing Decision (EU) 2023/941 as regards harmonised standards for mountaineering equipment, helmets for equestrian activities and gloves drafted in support of Regulation (EU) 2016/425 of the European Parliament and of the Council.

Annex I to Implementing Decision (EU) 2023/941 is amended in accordance with following table:

Entry	Amendment
63a	The following text is inserted: EN 892:2012+A3:2023 - Mountaineering equipment – Dynamic mountaineering ropes – Safety requirements and test methods
77a	The following text is inserted: EN 1384:2023 - Helmets for equestrian activities
84	It is deleted
84a	The following text is inserted: EN ISO 10819:2013 - Mechanical vibration and shock – Hand-arm vibration – Measurement and evaluation of the vibration transmissibility of gloves at the palm of the hand (ISO 10819:2013) EN ISO 10819:2013/A1:2019 EN ISO 10819:2013/A2:2022
112a	The following text is inserted: EN 13089:2011+A3:2023 - Mountaineering equipment – Ice-tools – Safety requirements and test methods

Standard updates

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

(*) Date of withdrawal: 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 360:2023	Personal fall protection equipment - Retractable type fall arresters	2025-06-30	EN 360:2002
EN ISO 12311:2023	Personal protective equipment - Test methods for sunglasses and related eyewear (ISO 12311:2023)	2024-06-30	EN ISO 12311:2013

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