Chemicals | Monthly bulletin | January 2022

Eurofins newsflash Chemical

Europe

Most products sold on-line do not comply with EU chemical legislations

In December 2021, The European Chemicals Agency (ECHA) published a report on its eighth REACH-EN-FORCE project:

REF-8 project report on enforcement of CLP, REACH and BPR duties related to substances, mixtures and articles sold online

It was carried out during 2020 in 29 countries of the EEA and Switzerland with the aim of inspect professional and consumer products sold online for restricted chemicals against relevant EU chemicals legislation such as CLP, REACH and BPR.

The rate of non-compliance with restrictions in substances/mixtures and articles was at 95% and 25% respectively.

The ECHA recommends that national authorities continue to hold inspections of products sold online and organise campaigns to raise awareness of problems with online sales, helping consumer to make better decisions when buying products online.

For more information, consult the ECHA website here.

Recent publications of amendments to REACH Regulation

In November and December 2021, the European Union (EU) published several amendments related to REACH and its annexes. Below a table summarising these recent publications:

Publication date	Reference	Amendment to	Date in force
22/11/2021	Regulation (EU) No 2021/2030	Annex XVII to Regulation (EC) No 1907/2006 of REACH. N,N-dimethylformamide (CAS No 68-12-2) was added as Entry 76 in Annex XVII.	09/12/2021
24/11/2021	Regulation (EU) No 2021/2045	Annex XIV to Regulation (EC) No 1907/2006 of REACH. This amendment replaces the information Annex XIV to REACH for entries 4 to 7.	13/01/2022
14/12/2021	Regulation (EU) No 2021/2204	Annex XVII to Regulation (EC) No 1907/2006 of REACH as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances. This amendment adds substances in Appendix 2 of Entry 28, in Appendix 4 of Entry 29 and in Appendix 6 of Entry 30.	03/01/2022

Additional recent updates regarding REACH

The below table showcases a summary of the most recent updates (non-exhaustive) regarding REACH Regulation (EC) No 1907/2006:

Summary of the Most Recent Updates
Date	Subject	Link
03/11/2021	Publication of the updated manual: *“How to prepare a downstream user report*” This provides support to downstream users using, creating or modifying nanoforms.	For more information, consult the ECHA website here.
03/11/2021	Publication of the report: *Causal impacts of the REACH Authorisation process on the use of substances of very high concern in the EU.* This presents two case studies that seek to quantify the causal effects that regulatory actions under the REACH Authorisation title have had on the use of specific substances of very high concern (SVHCs) in the EU/EEA.	For more information, consult the ECHA website here.
10/11/2021	ECHA has collaborated on the EFSA's Draft opinion on the identification and prioritisation for risk assessment of plasticisers used in food contact materials. The consultation was open until 16 December 2021.	For more information, consult the EFSA website here.
10/11/2021	Nanomaterials in the work place - Invisible but not negligible	For more information, consult the EUON website here.
11/11/2021	Publication of report: *Chemical Recycling of Polymeric Materials from Waste in the Circular Economy* The report commissioned by ECHA investigates the current knowledge on chemical recycling of polymeric materials, such as plastics and rubber from waste.	For more information, consult the ECHA website here.
15/11/2021	Publication of report: *Study on the Product Lifecycles, Waste Recycling and the Circular Economy for Nanomaterials* This updates and expands on the document “Nanomaterials in Waste Streams – Current Knowledge on Risks and Impacts” published by OECD in 2016.	For more information, consult the ECHA website here.
22/11/2021	Highlights from November Enforcement Forum meeting	For more information, consult the ECHA website here.
07/12/2021	First assessments of regulatory needs for groups of chemicals published	For more information, consult the ECHA website here.
09/12/2021	Scientific committees support further restrictions of PFAS The Committees for Risk Assessment and Socio-Economic Analysis support Germany’s proposal to restrict the use of undecafluorohexanoic acid (PFHxA) and related substances.	For more information, consult the ECHA website here.
15/12/2021	New web page on phthalates.	Visit the new ECHA section web here.

Other interesting links about REACH from ECHA’s website

European public initiatives

Please find below a table summarising recent public initiatives (non-exhaustive):

Feedback period	About this initiative
08 November 2021 - 06 December 2021	Persistent organic pollutants – setting limit values in Annex I (update) EU rules implement the EU’s international commitments under the Stockholm Convention on Persistent Organic Pollutants (chemical substances). Hexachlorobenzene, a substance used in pesticides, is listed in Annex A to the Stockholm Convention (elimination) and in Annex I to EU Regulation 2019/1021. This initiative amends Annex I, which does not currently set a limit on the amount of hexachlorobenzene permissible as an unintentional trace contaminant in substances, mixtures and articles.
30 November 2021 - 18 January 2022	Microplastics pollution – measures to reduce its impact on the environment This initiative aims to tackle microplastics unintentionally released into the environment. It will focus on labelling, standardisation, certification and regulatory measures for the main sources of these plastics.
06 December 2021 - 18 January 2022	Food safety – recycled plastic in food packaging (updated rules) All materials used with food must be safe and therefore contain no toxic contaminants. EU rules require individual authorisations for plastic recycling processes.
24 November 2021 - 16 February 2022	Chemicals – simplification and digitalisation of labelling requirements The EU aims to improve the communication of essential information on chemicals and in so doing reduce the adverse effects of hazardous chemicals on health and the environment. To contribute to these goals, this initiative will consider simplifying and streamlining labelling requirements for some categories of chemicals and chemical products, and the use of digital labelling.

Technical publications

Please find below a table summarising recent technical publications (non-exhaustive):

Date	Entity	Title
02/12/2021	CEFIC (European Chemical Industry Council)	Upcoming EU chemical Legislation Puts Europe’s Fourth Largest Manufacturing Industry At Crucial Crossroads Industry leaders made a call to the European Commission to work on the objectives of the EU Green Deal of Chemical Industry. This call follows the release by European Chemical Industry Council (Cefic) on the business impacts of the EU Chemicals Strategy for Sustainability (CSS).
08/11/2021	German Federal Institute for Risk Assessment (BfR)	Innovative, non-animal methods for risk assessment of chemicals in the centre of interest
10/11/2021	German Federal Institute for Risk Assessment (BfR)	For safe tattoo inks: BfR event promotes exchange between scientists, lawmakers and manufacturers

Recent Updates regarding CLP

The table below showcases a summary of the most recent updates (non-exhaustive) regarding CLP Regulation (EC) No 1272/2008:

Summary of the Most Recent Updates
Date	Subject	Link
10/11/2021	Social media campaign: Why the UFI matters for everybody	For more information, consult the Poison centres website here.

Other interesting links about CLP from ECHA’s website

France

Public Consultation about AGEC law

Over the last months, two public consultations have taken place about the same French draft Decree related to the framework of article 13.I of the AGEC law (Law nº 2020-105 of February 10 2020). The aim is to limit waste and preserve natural resources and biodiversity and limit climate change.

This decree put out for consultation specifies the definitions of the various environmental characteristics and qualities of products, the sectors and categories of products concerned, and the procedures for making information available.

Decree on consumer information on the environmental qualities and characteristics of waste-generating products (2021/644/F).

Summary of the main relevant information:

Consumer information on the presence of a hazardous substance shall apply where it is present in a concentration greater than 0.1% by mass in a substance, mixture or article according to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 (REACH).

This information shall be expressed by the words « contient une substance dangereuse » (in English “contains a hazardous substance”) or, where the hazardous substance present is that referred to in the first paragraph of Article R. 541-219, by the words « contient une substance extrêmement préoccupante » (in English “contains a substance of very high concern”). The information shall be supplemented by the name of each hazardous substance present.

This way of making the information available does not apply to substances with proven, suspected and presumed endocrine disrupting properties laid down by order referred the Public Health Code.

The information shall be made available no later than 18 months after the substance is identified as a hazardous substance.

For containers and contents of chemical products, these shall indicate the environmental qualities and characteristics and recyclability information as described in the Decree for information to consumers.
For all products and packaging, the use of words such as « biodégradable » (“biodegradable” in English), « respectueux de l’environnement » (translated in English as “environmentally friendly”) or any other equivalent are prohibited.

It has been decreed that this measure was effective from January 1, 2022.

Other recently published French legislation related to hazardous substances, French environment code and waste are:

Decree No. 2021-1285 of October 1, 2021 on the identification of hazardous substances in waste-generating products
Order of 1 October 2021 laying down specifications for eco-organisations and individual systems of the extended responsibility chain of producers of the contents and containers of chemicals that may present a significant risk to health and the environment mentioned in 7 ° of the article L. 541-10-1 of the environment code and falling under categories 1 ° to 10 ° of article R. 543-228

Denmark

Legislative changes in Danish POP

The Regulation (EU) 2019/1021 on persistent organic pollutants is a binding legislative act that is applied in its entirety across the EU, including Denmark.

On 1^st January 2021, the following Danish legislation on persistent organic pollutants (POPs):

Executive Order no. 820 of September 29, 2003 on certain POPs.
Executive Order no. 854 of September 5, 2009 restricting PCP to less than 5 mg/kg in goods.

were repealed as indicate in the following executive order published on 5^th October 2021:

Executive Order repealing the Executive Order on certain persistent organic compounds (POPs) (BEK no. 1895 of 04/10/2021).
Executive Order repealing the Executive Order banning the import, sale, use and export of products containing pentachlorophenol (PCP) (BEK no. 1896 of 04/10/2021).

On this same date Denmark’s Ministry of the Environment published the Executive Order (BEK no. 1894 of 04/10/2021) on persistent organic pollutants. It indicates that the performance of tasks pursuant to Regulation (EU) No 2019/1021 on persistent organic pollutants is of the Ministry of the Environment and its institutions. This order entered into force on 10^th October 2021.

Recent updates regarding UK REACH and GB CLP

The below table showcases a summary of the most recent updates (non-exhaustive) regarding UK REACH and GB CLP:

Summary of the Most Recent Updates
Date	Subject	Link
06/10/2021	Draft recommendation of priority substances to be included in Annex 14 (list of substances subject to Authorisation) of UK REACH 2021 The HSE has published draft recommendations for the potential inclusion of two substances in Annex 14 of UK REACH. The two substances concerned are disodium octaborate and dicyclohexyl phthalate (DCHP).	Draft can be consulted here.
13/12/2021	Updating the GB mandatory classification and labelling list (GB MCL List)	HSE GB CLP publication table can be consulted here.

EPA updates to Confidential Status of 377 Chemicals on the TSCA Inventory

WASHINGTON (October 13, 2021), EPA updates the confidential status of 377 chemical identities, and will include these chemical identities in the next update of the TSCA Inventory, planned for winter 2022.

The complete notification can be found here.

EPA will extend the compliance date of PBT substance PIP (3:1)

As required under the Toxic Substances Control Act (TSCA), EPA issued five final rules on January 6, 2021, to reduce exposures to certain chemicals that are PBT. These chemicals contain DecaBDE, HCBD, PCTP, PIP (3:1) and 2,4,6-TTBP.

In October 2021, EPA extended the PIP (3:1) compliance date to October 31, 2024.

The completed notification can be found here.

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/USA/1792	US	Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1); Further Compliance Date Extension
G/TBT/N/USA/1795	US	Safer Consumer Products: Priority Products List; Nail Products Containing Toluene
G/TBT/N/CHE/263	Switzerland	Draft Ordinance of the Federal Council concerning amendments to annexes 1.1, 1.2, 1.4, 1.5, 1.6, 1.10, 1.16, 2.9, 2.10 und 2.11 of the Ordinance on the Reduction of Risks relating to the Use of Certain Particularly Dangerous Substances, Preparations and Articles (Chemicals Risk Reduction Ordinance, ORRChem, Fedlaw number: SR 814.81) It proposes to revise the chemical risk reduction ordinance.
G/TBT/N/CHE/264	Switzerland	Annex 3 of the Ordinance on Protection against Dangerous Substances and Preparations (Chemicals Ordinance) The aim is to align the candidate list of substances pf very high concern (SVHC) with the EU’s Candidate List (REACH).
G/TBT/N/CHE/265	Switzerland	Annex 1.10 of Chemical Risk Reduction Ordinance (ORRChem) The aim is to align CMR substance requirements with REACH.
G/TBT/N/JPN/719	Japan	Partial amendment to the Poisonous and Deleterious Substances Designation Order.
G/TBT/N/USA/1807	US	Significant New Use Rules on Certain Chemical Substances (21-2.5e)