Contents by Eurofins SL&TH Regulatory Services Team
Chemical
European PFAS restriction proposal: Europe’s largest substance-banning project ever
On 13th 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 7th 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 being a threat to 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 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: 2nd stakeholder consultation
October: Start of drafting of proposal |
| 2023 | 13th January 2023: Submission of the dossier with the new proposal |
| 7th February 2023: The new proposal is published by ECHA. | |
| 22nd March: Open consultations for 6 months (until 22nd September 2023) | |
| 5th 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.
For details on our PFAS testing services including Total Organic Fluorine, visit our PFAS testing webpage.
European Initiatives related to POP legislation
Recent initiatives by the European Commission related to POP legislation includes
| Initiative | State |
| Persistent organic pollutants – perfluorohexane sulfonic acid (PFHxS).
This initiative amends Annex I to the Regulation (EU) 2019/1021, which implements 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. |
The feedback period was 9th February 2023 until 9th 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 |
| 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. |
US 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 27th, 2023. Businesses have until January 27th, 2024 to comply with Proposition 65’s clear and reasonable warning requirements. The table below lists the chemicals added:
| Chemical | CAS # | Type of Toxicity | Listing Date |
| Glycidyl methacrylate cancer | 106-91-2 | Cancer | January 27th, 2023 |
| 1-Bromo-3-chloropropane | 109-70-6 | Cancer | January 27th, 2023 |
| 1-Butyl glycidyl ether | 2426-08-6 | Cancer | January 27th, 2023 |
Sustainability, environmental and circular economy
Miscellaneous technical publications relating to environmental, plastics, packaging and waste
| Date | Country/ Region | Publication |
| 01/01/2023 | Italy | The deferral of plastic tax.
On 1st January 2023, 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 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 provides 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 3rd march 2023, the public consultation related to the 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’s aim is to promote textile product sustainability and reduce 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:
On other hand, the Coordination Center for Textile Recycling (CORID) was set up. It is made up of all the individual and collective management systems recognized by the Ministry. For more information, consult the MASE ‘s website here. |
Cosmetics & Personal Care
Consider the rinseability 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 rinseability of your product.
As part of the instrumental approach, rinsing time measurements are performed by an experienced technician and applied by a standardised gesture. The efficiency of the rinsing can be verified by the following criteria: no visual foam, no foam after massaging, no foam after combing, and clear rinse water.
To assess consumer perception, panellists evaluate rinseability. 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 rinseability 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.
Softlines & Leather
European 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 15th 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 movement of goods.
The French authorities have two months to respond to the concerns raised by the Commission.
Italy Extends responsibility for textile producers
On 3rd 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 of the collection, initiation and preparation for re-use, recycling and recovery of waste deriving from textile products.
- The producer will be able to fulfil 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 fibres 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 labelling system that describes characteristics and fibre 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.
Toys, Childcare & Hardlines
European 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 15th 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 movement of goods.
The French authorities have two months to respond to the concerns raised by the Commission.
France ERP and Environmental Code publication
| Date | Publication |
| 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. |
Italy defers plastics tax
On 1st 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 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.
Italy’s new CONAI’s guidelines for the environmental labelling of packaging
On 13th January 2023, the Italian National Packaging Consortium (CONAI) published a full series of specific guidelines for product packaging for different sectors. The guidelines are:
- Guidelines for environmental labelling: electrical and electronic equipment, January 2023
- Packaging Labelling Guidelines for Packaging manufacturers, October 2022
- Packaging Labelling Guidelines for Self-Adhesive Tapes, October 2022
- Packaging Labelling Guidelines for the Chemical Sector, October 2022
- Guidelines for Businesses: Environmental Labelling for Packaging, October 2021
