Chemicals | Monthly bulletin | October 2023

Eurofins newsflash Chemical

Europe

New restriction for microplastics

On the 27^th September 2023, the European Commission published an amendment to the Regulation (EC) No 1907/2006 (REACH) on intentionally added microplastics restriction.

The amendment consists of a new entry 78 in Annex XVII under the EU chemical legislation REACH which restricts synthetic polymer microparticles and two new appendices 15 and 16 which indicate rules on proving degradability and solubility of these microplastics.

This restriction covers all intentionally added synthetic polymer particles below five millimetres that are organic, insoluble and resist degradation and indicates that they “Shall not be placed on the market as substances on their own or, where the synthetic polymer microparticles are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0,01 % by weight.”

Inside the scope of this new restriction: fragrances, cosmetics, detergents, fabric softeners, glitter, toys, medicine and medical device, fertilisers, granular infill material used on artificial sport surfaces amongst others.

This new amendment will come into force on the 17^th October 2023 with different transitional periods for application of the restriction in specific type of uses and for suppliers to provide specific information and labelling requirements on certain products. Below is a summary table:

Transitional periods in specific type of uses
Date	Category or type of product
17^th October 2027	Rinse-off products unless such products are covered by the line of this table or contain synthetic polymer microparticles for use as an abrasive, i.e. namely to exfoliate, polish or clean (“microbeads”).
17^th October 2028	Detergents, waxes, polishes and air care products, unless those products are covered by the first line of this table or contain microbeads.
17^th October 2028	Fertilising products which do not fall within the scope of Regulation (EU) 2019/1009.
17^th October 2028	Products for agricultural and horticultural uses not covered by the previous lines of this table.
17^th October 2029	Synthetic polymer microparticles for use in the encapsulation of fragrances.
17^th October 2029	Leave-on products unless such products are covered by the previous lines of this table.
17^th October 2029	Devices (Regulation (EU) 2017/745), unless those devices contain microbeads.
17^th October 2031	Plant protection products and seeds treated with those products, and biocidal products.
17^th October 2031	Granular infill for use on synthetic sports surfaces.
17^th October 2035	Lip, nail and make-up products, unless such products are covered by the previous lines of this table or contain microbeads.

Transitional periods for suppliers to provide specific information and labelling requirements
Date	Category or type of product
17^th October 2025	Suppliers of synthetic polymer microparticles for use at industrial sites, shall provide the following information: Instructions for use and disposal to prevent releases of synthetic polymer microparticles to the environment. The following statement: “The synthetic polymer microparticles supplied is subject to conditions laid down by entry 78 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council”. The information on quantity or, as applicable, concentration of synthetic polymer microparticles in the substance or mixture. Generic information on the identity of the polymers contained in the substance or mixture that enables manufacturers, industrial downstream users and other suppliers to comply with their obligations.
17^th October 2025	Suppliers of food additives, synthetic polymer microparticles which are contained by technical means, synthetic polymer microparticles the physical properties of which are permanently modified during intended end use and synthetic polymer microparticles which are permanently incorporated into a solid matrix, shall provide instructions for use and disposal explaining to professional users and the general public how to prevent releases of synthetic polymer microparticles into the environment.
17^th October 2026	Suppliers of vitro diagnostic device products shall provide instructions for use and disposal explaining to professional users and the general public how to prevent releases of synthetic polymer microparticles into the environment.
From 17^th October 2031 until 16^th October 2035	Suppliers of lip, nail, and make-up products containing synthetic polymer microparticles shall provide the following statement: “This product contains microplastics.” Note: Products placed on the market before the 17^th October 2031 are not required to bear that statement until the 17^th December 2031.
Note: The information shall be provided in the form of clearly visible, legible and indelible text or in the form of pictograms. The text or pictograms shall be placed on the label, the packaging, or the package leaflet of the products or on the safety data sheet. In addition to the text or pictograms, suppliers may provide a digital tool that gives access to an electronic version of that information. Where instructions for use and disposal are in the form of a text, they shall be in the official languages of the Member States where the substance or mixture is placed on the market, unless the Member States concerned provide otherwise.

Information to submit to the ECHA by 31 May of each year
Date	Type of operator	nformation
2026	Manufacturers and industrial downstream users of synthetic polymer microparticles in the form of pellets, flakes, and powders used as feedstock in plastic manufacturing at industrial sites	A description of the uses of synthetic polymer microparticles in the previous calendar year. For each use of synthetic polymer microparticles, generic information on the identity of the polymers used. For each use of synthetic polymer microparticles, an estimate of the quantity of synthetic polymer microparticles released to the environment in the previous calendar year, which shall also include the quantity of synthetic polymer microparticles released to the environment during transportation. For each use of synthetic polymer microparticles, a reference to the derogation for use at industrial sites.
2027	Other manufacturers of synthetic polymer microparticles and other industrial downstream users using synthetic polymer microparticles at industrial sites
2027	Suppliers of medical devices, food additives, in vitro diagnostic devices, synthetic polymer microparticles which are contained by technical means, synthetic polymer microparticles the physical properties of which are permanently modified during intended end use and synthetic polymer microparticles which are permanently incorporated into a solid matrix placed on the market for the first time to professional users and the general public.	A description of the end uses for which the synthetic polymer microparticles were placed on the market in the previous calendar year. For each end-use generic information on the identity of the polymers placed on the market in the previous calendar year. For each end use, an estimate of the quantity of synthetic polymer microparticles released to the environment in the previous calendar year, which shall also include the quantity of synthetic polymer microparticles released to the environment during transportation. For each use of synthetic polymer microparticles, a reference to the applicable derogation or derogations.

The restriction shall not apply to placing on the market of synthetic polymers microparticles, on their own or in mixtures, before the 17^th October 2023. However, this date shall not apply to the placing on the market of synthetic polymers microparticles for uses listed in the first table of this bulletin.

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

35 new substances subject to export notification

On the 25^th August 2023, the European Commission published the Regulation (EU) 2023/1656 which amends Regulation (EU) No 649/2012 regarding EU’s Prior Informed Consent (PIC).

The amendment adds 35 hazardous chemicals, 27 pesticides and 8 industrial chemicals, to Annex I of Regulation (EU) No 649/2012. Now the list contains 295 entries which indicates the chemicals subject to export notification and explicit consent from the importing country.

The aim of this regulation is to govern the trade of certain hazardous chemicals that are banned or severely restricted in the EU.

This regulation came into effect on the 14^th September 2023.

If you would like to view the list of the newly added chemicals in Annex I, please consult the official publication here.

Recent publications 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
30/08/2023	Restriction proposal for bisphenols withdrawn. The German authorities have withdrawn their proposal to restrict bisphenols that have endocrine disrupting properties to the environment from the opinion-making process by ECHA’s scientific committees. They intend to re-submit an updated proposal to the ECHA.	For more information, consult the ECHA’s website here.
30/08/2023	ECHA's database on chemicals in EUCLEF. Regulatory information has been updated for: Plant Protection Products Regulation EU Ecolabel Regulation Construction Products Regulation (Hazardous Substances and SDS and Declaration) In Vitro Diagnostic Medical Devices Regulation Medical Devices Regulation Marine Environmental Policy Framework Directive General Product Safety Directive Pesticide Residues Regulation RoHS Directive Legislation profiles have been updated for: Inland Transport of Dangerous Goods Directive Pesticide Residues Regulation Plant Protection Products Regulation RoHS Directive	For more information, consult the ECHA’s website here.
06/09/2023	OECD eChemPortal updated. ECHA’s database of REACH registrations on over 1.3 million endpoints for 27 000 registered substances can be found on the OECD eChemPortal.	For more information, consult the ECHA’s website here.
06/09/2023	Six proposals to identify new substances that are of very high concern. These substances are: 2,4,6-tri-tert-butylphenol (EC 211-989-5). 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol (EC 221-573-5). 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one (EC 438-340-0). ·Bumetrizole (EC 223-445-4). Dibutyl phthalate (EC 201-557-4). Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol (List No. 700-960-7).	For more information, consult the ECHA’s website here.
13/09/2023	Nanopinion Recent progress towards microbiota-inclusive nanosafety research.	For more information, consult the EUON’s website here.
20/09/2023	Open access to book chapter “Nanoregisters in Europe” The chapter introduces the creation of national nano inventories and covers the Cosmetic Products Notification Portal and EUON in separate sub-chapters.	For more information, consult the EUON’s website here.

Other interesting links about REACH from the ECHA’s website

Interesting links about CLP on the ECHA’s website

France

Additional list of dangerous substances published

On the 14^th September 2023, the Minister of Ecological Transition and Territorial Cohesion published Order of 30 August 2023 relating to the presence of dangerous substances in products generating waste.

One of the decrees (text No 15) establishes a first list of substances whose level of concern is comparable to substances of very high concern, in accordance with the recommendations of ANSES in its opinion issued on 25 March 2021. The listed substances are:

Diisooctyl phthalate (CAS No. 27554-26-3)
1,3-benzenediol (resorcinol) (CAS No. 108-46-3)

Another decree (text No 16) designates an alternative method, Scan4Chem of informing consumers with specific information relating to the presence of dangerous substances in products generating waste through product barcode which can be scanned by consumers.

AGEC Law (no. 2020-105 of February 10, 2020), relating to the fight against waste and the circular economy, created the Article L. 541-9-1 of the environmental code which provides for the possibility of expanding and strengthening the information obligations for products generating waste, particularly in a dematerialized format. Decree No. 2021-1285 of 1 October 2021 relating to the identification of dangerous substances in products generating waste defines that the list of these substances is made up of a list of substances of extremely high concern (SVHC List according to REACH) added to the list of substances whose level of concern is comparable, this second list being established after advice from the National Agency for Food, Environmental and Occupational Health Safety.

This came into effect on the 15^th September 2023.

For more information, consult the official publication here.

Japan

Japan Regulates 3 POPs Chemicals Under Chemical Substances Control Law

At the 11^th meeting of the Conference of the Parties to the Stockholm Convention held on the 5^th May , 2023, the member countries collectively agreed to include three new persistent organic pollutants (POPs) to the Annex A list for elimination.

On the 10^th August, 2023, the Ministry of Economy, Trade and Industry (METI) announced the inclusion of the three POPs to the Class I Specified Chemical Substances List under the Chemical Substances Control Law (CSCL). Following deliberations regarding the designation of import-prohibited products and exempted uses of the three substances, the implementation of specific measures are expected to come in the autumn of 2024.

For details of the three POPs, please see table 1 below:

Chemicals	CAS Number
Methoxychlor	72-43-5
Dechlorane Plus	13560-89-9
UV-328	25973-55-1

Source: oshirase_230810.pdf (meti.go.jp)

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
Secretariat of Environment and Natural Resources of Mexico	24/07/2023	Official Mexican Standard NOM-152-SEMARNAT-2023, which establishes the criteria and specifications of the content of sustainable forest management programs for the use of timber forest resources in forests, jungles and vegetation in arid areas.
European Commission	18/08/2023	Opinion of the European Economic and Social Committee on the proposal for a Directive of the European Parliament and of the Council on common rules promoting the repair of goods and amending Regulation (EU) 2017/2394 and Directives (EU) 2019/771 and (EU) 2020/1828 (COM(2023) 155 final — 2023/0083 (COD))
European Commission	18/08/2023	Opinion of the European Economic and Social Committee on the proposal for a directive of the European Parliament and of the Council on substantiation and communication of explicit environmental claims (Green Claims Directive) (COM(2023) 166 final — 2023/0085 (COD))
French Ministry of ecological transition and territorial cohesion	31/08/2023	Decree No. 2023-843 of 30 August 2023 amending Decree No. 2022-410 of 23 March 2022 relating to the terms of certification and control of the European Ecolabel
European Commission	24/08/2023	Energy labelling - electronic displays (review of requirements) This consultation covers both the Eco-design and Energy labelling interlinked initiatives.
European Commission	04/09/2023	EU consumer programme – evaluation Its actions aim to support consumer protection objectives where they cannot be sufficiently achieved by Member States acting alone due to the cross-border nature of the issues involved.
UK Department for Environment, Food & Rural Affairs	04/09/2023	The Fluorinated Greenhouse Gases (Amendment) Regulations 2023 Statutory guidance was published which contains several statutory instruments and explanatory memorandums.
European Parliament	20/09/2023	Eco-design requirements for sustainable products in “A European Green Deal”.
UK Government	13/09/2023	The Greenhouse Gas Emissions Trading Scheme Auctioning (Amendment) Regulations 2023 (S.I. 2023 No. 994).
Ministry of Ecological Transition and Territorial Cohesion of France	14/09/2023	Order of 30 August 2023 relating to the identification of dangerous substances in products generating waste. This decree establishes the supplementary list of dangerous substances whose level of concern is comparable to substances of very high concern, and of which are not published on the list mentioned in Article 59, paragraph 10, of Regulation (EC) No 1907/2006 related to the identification of hazardous substances in waste-generating products.
Ministry of Ecological Transition and Territorial Cohesion of France	14/09/2023	Order of 30 August 2023 relating to the provision of information on the presence of dangerous substances in products generating waste by means of an application.
European Commission	20/09/2023	Chemicals regulation – update of EU rules for test methods Status: Public initiative in preparation and planned for fourth quarter 2023.
European Commission	20/09/2023	National Emission Reduction Commitments Directive – evaluation Status: Public initiative in preparation and planned for fourth quarter 2024.
European Commission	20/09/2023	Endangered wild fauna and flora – updated rules for permits, certificates and other documents (CITES) Status: Public initiative in preparation and planned for second quarter 2024.
European Commission	21/09/2023	Environmental Footprint methods The European Commission has proposed the Product Environmental Footprint and Organisation Environmental Footprint methods as a common way of measuring environmental performance.
European Commission	21/09/2023	PEF Apparel & Footwear There is a plethora of methodologies, certifications, and product labels used in the apparel & footwear industry. The Product Environmental Footprint (PEF) is a methodology measuring the environmental footprint of products following similar rules across the European Union.
Re-Fashion	21/09/2023	Apparel & Footwear Product Environmental Footprint Category Rules (PEFCR)