Chemicals | Monthly bulletin | February 2024

Eurofins newsflash 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.