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Europe

New 5 substances in Annex XIV to REACH (Authorisation list)

On 11^th April 2022, the European Commission published the following amendment related to REACH:

Commission Regulation (EU) 2022/586 of 8 April 2022 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

It adds the following substances to the table in Annex XIV to REACH Regulation:

Tetraethyllead (TEL)(EC 201-075-4, CAS 78-00-2);
4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol [with ≥ 0.1% w/w of Michler's ketone(EC 202-027-5) or Michler's base (EC 202-959-2)] (EC 209-218-2, CAS 561-41-1);
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) [with ≥ 0,1% w/w 4-heptylphenol, branched and linear (4-HPbl)](EC -, CAS -);
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)(EC 239-622-4, CAS 15571-58-1); and
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)(EC -, CAS -).

ECHA has published a report forecasting the number of applications expected for the five substances added to the Authorisation List.

For more information, consult the official publication here.

Recent updates regarding REACH

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

Summary of the Most Recent Updates
Date	Subject	Link
22/03/2022	Highlights from March RAC and SEAC meetings The main points are: REACH restrictions (Dechlorane Plus, 2,4-dinitrotoluene between other substances). Applications for authorisation (1,2-dichloroethane between other substances). Occupational exposure limits (1.4-dioxane between other substances). RAC adopts 10 opinions on harmonised classification and labelling.	For more information, consult the ECHA website here.
22/03/2022	Publication of Community rolling action plan update covering the years 2022, 2023 and 2024. ECHA lists 27 substances for evaluation by EU Member States under the Community rolling action plan (CoRAP) for 2022-2024	For more information, consult the ECHA website here.
23/03/2022	ECHA is currently running a consultation on its proposal to include eight new substances of very high concern in the REACH Authorisation List. Comments can be given by 2 May 2022	For more information, consult the ECHA website here.
06/04/2022	ECHA and the Member States have assessed a group of 148 bisphenols and recommended that more than 30 bisphenols need to be restricted due to their potential hormonal or reprotoxic effects.	For more information, consult the ECHA website here.
04/04/2022	ECHA has launched 26 new consultations on testing proposals. The deadline for comments is 16 May 2022. There are currently 27 open consultations on testing proposals.	For more information, consult the ECHA website here.
04/04/2022	The ECHA Use Maps library has been updated with A.I.S.E. (International Association for Soaps, Detergents and Maintenance Products) elements.	For more information, consult the ECHA website here.
12/04/2022	On 14th October 2022, the update of the REACH annexes will start to apply. ECHA is updating its guidance materials and will publish advice related to information requirements for registrants in the second half of 2022.	For more information, consult the ECHA website here.
12/04/2022	ECHA has published reports for the following groups of substances: dialkyl (and diaryl) dithiophosphates (DDPs); esters from branched or non-aromatic cyclic dicarboxylic acids and aliphatic alcohols; imidazoles; N-alkoxy-2,2,6,6-tetramethylpiperidine derivatives; phthalic anhydrides and hydrogenated phthalic anhydrides; and simple lithium compounds.	For more information, the ECHA website here.

Other interesting links about REACH from the ECHA’s website

Other interesting links about CLP from the ECHA’s website

Update of PIC substances list

On 20^th April 2022, the European Commission published the following amendment related to the export and import of hazardous chemicals:

Commission Delegated Regulation (EU) 2022/643 of 10 February 2022 amending Regulation (EU) No 649/2012 of the European Parliament and of the Council as regards the listing of pesticides, industrial chemicals, persistent organic pollutants and mercury and an update of customs codes.

The main points are the new texts for:

Annex I - List of chemicals:

Part 1- List of chemicals subject to export notification procedure (referred to in Article 8)

Part 2- List of chemicals qualifying for PIC notification (referred to in Article 11)

Part 3 - List of chemicals subject to the PIC procedure (referred to in Articles 13 and 14)

ANNEX V - Chemicals and articles subject to export ban (referred to in Article 15)

Part 1 and part 2.

It shall apply from 1^st July 2022.

To see the complete list , consult the official publication on the European Commission website here.

European public initiatives

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

Commission adoption planned for

About this initiative

Third quarter 2022

Electrical equipment – hexavalent chromium as an anticorrosion agent in gas absorption heat pumps (RoHS exemption)

This initiative concerns a request for an exemption for hexavalent chromium as an anti-corrosion agent in the working fluid of the carbon steel sealed circuit of gas absorption heat pumps, which are considered to be EEE.

Fourth quarter 2022

Persistent organic pollutants – perfluorohexane sulfonic acid (PFHxS)

This initiative amends Annex I to the Regulation to include PFHxS, its salts and PFHxS-related compounds as substances that are subject to certain restrictions. These substances are expected to be listed under the Convention by the end of 2022.

Standards 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.

(**) Date of announcement: latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level.

CEN
Reference	Title	*Date of withdrawal ()**	Supersedes
EN ISO 638-1:2022	Paper, board, pulps and cellulosic nanomaterials - Determination of dry matter content by oven-drying method - Part 1: Materials in solid form (ISO 638-1:2022)	2022-10-31	EN ISO 638-1:2021
EN ISO 638-2:2022	Paper, board, pulps and cellulosic nanomaterials - Determination of dry matter content by oven-drying method - Part 2: Suspensions of cellulosic nanomaterials (ISO 638-2:2022)	2022-09-30	EN ISO 638-2:2021

Technical and Official publications

Below table includes some recent publications related to Chemicals:

Entity	Date	Publication
European Commission	04/03/2022	Notice to undertakings intending to import or export controlled substances that deplete the ozone layer to or from the European Union in 2023 and undertakings intending to produce or import these substances for essential laboratory and analytical uses in 2023 2022/C 104/14
European Commission	10/03/2022	Corrigendum to Commission Regulation (EU) 2021/1297 of 4 August 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and C9-C14 PFCA-related substances (Official Journal of the European Union L 282 of 5 August 2021)
Office for Product Safety and Standards (UK)	08/04/2022	Update of Guidance Regulations: restriction of hazardous substances (RoHS) for manufacturers, importers and distributors.
French journal official (France)	24/03/2022	Order of 21 February 2022 relating to the operation of the information system of poison control and toxicovigilance centers (SICAP)

Recent updates regarding UK REACH and GB CLP

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

Summary of the Most Recent Updates
Date	Subject	Link
31/03/2022	Updating the GB mandatory classification and labelling list (GB MCL List)	HSE GB CLP publication table can be consulted here.

Sweden

Sweden Ordinance (1998: 944) Chemicals Requirement

Sweden has a general ban on mercury and mercury-containing products under "Ordinance (1998: 944) on prohibitions etc. in certain cases in connection with handling, import and export of chemical products."

High risk materials have been added to the scope of the below test line.

Sweden Ordinance (1998: 944) on prohibitions etc. in certain cases in connection with handling, import and export of chemical products, section 9/ Document Review.

Products that contain mercury may not be placed on the Swedish market.

LoG/DoC that the products do not contain mercury should be provided for document review.

Do not apply to:

mercury that occurs naturally in coal, ore or ore concentrate,
batteries,
packaging and packaging components,
motor vehicles and trailers for these vehicles that are covered by the provisions on type approval in the Vehicle Ordinance (2009: 211),
light trucks and passenger cars other than EU-approved cars covered by section 2 of the Ordinance (2003: 208) on the prohibition of certain metals in cars,
in vitro diagnostic products referred to in the repealed Act (1993 : 584) on medical devices,
professional export of amalgam for dental use referred to in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83 / EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385 / EEC and 93/42 / EEC, if exported to another country in the European Union or the European Economic Area,
medicinal products for human use and veterinary medicinal products covered by the Medicinal Products Act (2015: 315) and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 establishing Community procedures for the authorisation and supervision of medicinal products for human use and veterinary medicinal products and establishing a European Medicines Agency,
if a corresponding prohibition on placing on the market or use follows from Annex XVII to Regulation (EC) No 1907/2006,
the uses permitted under the second sentence of Article 67 (1) and 18a.3, 18a.6 and 18a.8 in Annex XVII to Regulation (EC) 1907/2006,
professional export or importation of

(a) goods for repair or calibration abroad;

(b) military equipment for exercise, training or international activities; or

mercury-containing waste exported from Sweden for recycling or disposal, or
electrical and electronic equipment, cables and spare parts covered by the ordinance (2012: 861) on hazardous substances in electrical and electronic equipment. Regulation (2021: 632).

For more information, consult the KEMI (Swedish Chemicals Agency) website here.

Comments Regarding the Justification for the Phthalates Final Rule and the Cost-Benefit Analysis for Continuing the Interim Prohibition on DINP

On March 24^th 2022, the Consumer Product Safety Commission (CPSC) published in the Federal Register the following Request for Comments:

Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates.

Following a Federal court opinion remanding the CPSC’s final phthalates rules to allow the CPSC to address two procedural deficiencies found by the court, the CPSC is seeking public comment regarding the justification for the phthalates final rule and the cost-benefit analysis for continuing the interim prohibition on DINP.

Written comments should be submitted by May 9^th 2022.

New York Proposes to Restrict PFAS and Phthalates in Packaging

The State of New York has recently proposed to expand its toxics in packaging act to include restrictions for phthalates and PFAS. Under FY 2023 New York State Executive Budget: Transportation, Economic Development and Environmental Conservation – Article VII Legislation, Part SS, beginning December 31st, 2024, New York proposes to prohibit the distribution of packages and packaging components containing:

Phthalates, individually or in combination, in amounts exceeding 100 ppm by weight; and
PFAS, individually or in combination, in amounts exceeding 100 ppm by weight.

New York’s Hazardous Packaging Law already prohibits the distribution of packages and packaging components containing lead, cadmium, mercury or hexavalent chromium, individually or in combination, in amounts exceeding 100 ppm by weight. If the new proposed restrictions for phthalates and PFAS are enacted, New York’s packaging law will be in line with the 2021 updated Toxics in Packaging Clearinghouse (TPCH) Model Legislation.

Please click here to see the official text of the proposed bill.

New York Regulates Flame Retardants in Certain Consumer Products

On December 31^st 2021, the State of New York approved Bill A5418B to regulate covered flame retardants in certain consumer products. Beginning January 1st, 2024, no person shall sell or offer for sale any new upholstered furniture or mattress, that contains any intentionally added covered flame retardant chemical, individually or in combination.

Under the new regulation, a “covered flame retardant chemical” means any chemical that meets the following criteria:

A functional use for the chemical is to resist or inhibit the spread of fire or as a synergist to chemicals that resist or inhibit the spread of fire; and
The chemical is one of the following: a halogenated, organophosphorus, organonitrogen, or nanoscale chemical.

In addition, beginning January 1^st 2024, no person shall sell or offer for sale any electronic display that contains an intentionally added organohalogen flame retardant chemical in the enclosure or stand of such electronic display. Beginning January 1^st 2023, manufacturers of electronic displays must submit an annual report to the New York State Department of Environmental Conservation identifying all of the flame retardants used in the enclosure or stand of the electronic display in a form determined by the Department.

EPA Removes Last 2 PFAS from Safer Choice Program

On March 16^th, 2022, the Environmental Protection Agency (EPA) announced the removal of the last 2 PFAS substances listed on the Safer Chemical Ingredients List under EPA’s Safer Choice Program. The Safer Choice Program is a voluntary program that assists consumers and businesses find products containing safe ingredients. The following 2 PFAS substances that have been removed:

1-propanaminium, N-(carboxymethyl)-N,N-dimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulfonyl]amino]-, inner salt (CAS number: 449177-94-0)
boron, trifluoro(tetrahydrofuran)-, (T-4)-, polymer with 3-methyl-3-[(2,2,3,3,3-pentafluoropropoxy)methyl]oxetane, ether with 2,2-dimethyl-1,3-propanediol (2:1), bis(hydrogen sulfate), diammonium salt (CAS number: 452080-67-0)

For more details, please visit the EPA’s website here.

EPA Proposes to Amend Formaldehyde Emission Standards for Composite Wood Products

On March 29^th, 2022, the Environmental Protection Agency (EPA) issued in the Federal Register a proposed rule to update several voluntary consensus standards that are incorporated by reference in the formaldehyde standards for composite wood products under the Toxic Substances Control Act (TSCA). See Table 1 below for a summary of the proposed update of voluntary consensus standards:

Table 1:

Current Standard	Proposed Standard
ANSI/HPVA HP-1-2016	ANSI/HPVA HP-1-2020
ASTM D5055-16	ASTM D5055-19e1
ASTM D5456-14b	ASTM D5456-21e1
BS EN ISO 12460-3:2015(E)	BS EN ISO 12460-3:2020(E) ISO 12460-3:2020
JIS A 1460:2015(E)	JIS A 1460:2021
PS-1-09	PS-1-19
PS-2-10	PS-2-18

The EPA also proposed the following changes:

address remote inspections for third-party certifiers (TPCs) required to conduct on-site inspections in the event of unsafe conditions (e.g., COVID-19);
clarify testing data requirements for emission standards of no added formaldehyde-based resins and ultra-low-emitting formaldehyde resins to fully align with California Air Resource Board (CARB) quality control data;
clarify the period in which panels must be tested after their product their production to align with CARB; and
include equivalence determinations to align with CARB requirements

For more details of the proposed rule, please click here.

EPA Proposes to Ban the Use of Chrysotile Asbestos Under the TSCA

On April 12^th 2022, the Environmental Protection Agency (EPA) issued a proposed rule to ban the on-going use of Chrysotile Asbestos under Section 6(a) of the Toxic Substances Control Act (TSCA). To address the unreasonable risk identified in the TSCA Risk Evaluation for Asbestos, Part 1 from chrysotile asbestos, the EPA is proposing the following:

prohibit the manufacture, import, processing, and distribution in commerce of chrysotile asbestos-containing:
- diaphragms for use in the chlor-alkali industry
- sheet gaskets used in chemical production
- brake blocks used in the oil industry
- aftermarket automotive brakes/linings
- vehicle friction products and other gaskets
prohibit the manufacture, import, processing, and distribution in commerce of aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use and other chrysotile asbestos-containing gaskets for consumer use; and
disposal and recordkeeping requirements for the above conditions of use.

The EPA is accepting comments on the proposed rule until June 13^th 2022.

For more details on the proposed rule, please click here.

Washington State Passes PFAS Priority Products Law

On March 31^st 2022, the State of Washington enacted HB1694, which allows the Department of Ecology (DOE) to accelerate the regulation of PFAS-containing priority products under the Safer Products for Washington programme.

Under the new law, the DOE may determine and adopt regulatory actions without going through the standard five-year process, and firefighting personal protective equipment has been established as a priority product for PFAS chemicals. The DOE may also consider any product identified in the DOE’s final PFAS chemical action plan (dated November 2021) as a priority product, such as water-resistant clothing, non-stick cookware, personal care products, cleaning agents, automotive products, floor waxes and sealants, ski waxes, and car waxes.

For such products named as a priority product, the DOE is directed to:

determine an initial set of regulatory actions by June 1^st 2024; and
adopt rules to implement the initial set of regulatory actions by December 1^st 2025.

California Introduces Bill to Ban Intentionally Added Microplastics

California has recently introduced Assembly Bill (AB) 2787 to ban the sale of certain products, such as leave-on cosmetics, waxes and polishes, that contain intentionally added microplastics.

Under AB 2787, “Microplastic” is defined as a material consisting of solid polymer-containing particles, to which chemical additives or other substances may have been added, and 1 percent weight by weight (w/w) or more of the particles are either of the following sizes:

5 millimeters or less in all dimensions; or
for fibers, 3 nanometers to 15 millimeters, inclusive, in length and have a length to a diameter ratio of greater than 3.

The following products shall not be sold on the dates specified if it contains intentionally added microplastics:

Rinse-off cosmetics products – January 1^st, 2027
Leave-on cosmetic products – January 1^st, 2029
Detergents containing microbeads, encapsulated fragrance, or other microplastics – January 1^st, 2028
Waxes and polishes – January 1^st, 2028

California Proposition 65 Reformulations

California Proposition 65 is the ‘Safe Drinking Water and Toxic Enforcement Act of 1986’, which has been effective for almost 30 years. Due to the implementation of California Proposition 65, more and more court cases are being settled to reduce the exposure of carcinogenic and reproductive chemicals by reformulating the consumer products containing such chemicals.

In order to keep retailers and manufacturers up-to-date, the highlights of the consent agreements and settlements are summarised as below:

Product	Chemical	Limit	Case No
Hibachi Grill	Carbon Monoxide	Products shall utilise a warning statement.	San Francisco County Superior Court CGC-16-555429
Latex Resistance Bands	N-nitrosodiethylamine (NDEA)	10 ppb	Alameda County Superior Court RG21107796
Airpod Cases	Bisphenol A (BPA)	BPA-Free or utilise a warning statement	Out of Court Settlement
Leather Gun Slings	Chromium VI	Product shall utilise a warning statement	Out of Court Settlement
Safety glasses	Bisphenol A (BPA)	BPA-Free or utilise a warning statement	Out of Court Settlement
Cosmetics, Make-up Foundation and Concealer	Perfluorooctanoic Acid (PFOA)	No intentionally added PFOA or fluorinated ingredient that causes PFOA to be in a covered product, including but not limited to C9-15 fluoroalcohol phosphate	Alameda County Superior Court RG21091642
Baby Food Pouch	Acrylamide	20 ppb or utilise a warning statement.	Out of Court Settlement

California Proposes Second Modification of Prop 65 Short Form Warning Rule

On April 5^th, 2022, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued “Notice Second 15-Day Modification of Text for Proposed Amendment: Clear and Reasonable Warnings – Short Form.” After reviewing comments on the first modification, the OEHHA proposed the following significant changes:

Remove the label size and package shape limitations to allow the use of the short form warning on product labels of any size;
Remove the requirement that the font type size must be the same as the largest type size providing consumer information. The minimum 6-point type size requirement for short-form warnings remains unchanged; and
Modify the effective date of the regulation from one year to two years in order to allow additional time for businesses to implement changes to the short form.

For more details on the proposed changes, please click here.

Canada

Canada Updates Product Safety Laboratory Test Methods

Health Canada develops non-mandatory Product Safety Laboratory (PSL) test methods in order to provide assistance to the industry in understanding how Health Canada assesses products for compliance with mandatory regulations. Health Canada has recently updated the following PSL test methods (only chemistry-related methods have been listed below):

Chemistry Methods

Determination of Leachable Arsenic (As), Selenium (Se), Cadmium (Cd), Antimony (Sb), and Barium (Ba) in Applied Coatings (C03)
Determination of para-Phenylenediamine (PPD) in cosmetics and similar consumer products by GC-MS (C42)

For a full list of the PSL test methods, please click here.

Japan

Japan Proposes to Designate PFOA-Related Substances as Class I Specified Chemical Substances

On March 2^nd 2022, Japan announced a draft measure to designate PFOA-related substances as Class I Specified Chemical Substances under the Act on the Examination of Chemical Substances and Regulation of Manufacturing, etc. The proposed measure attaches a list of PFOA-related substances and aims to prohibit the import of the following products containing the listed substances:

Floor wax;
Protective agents and anti-fouling agents for textile products;
Water and oil repellent;
Textile products with water and oil repellency;
Antifoaming agent;
Coating agent;
Optical fiber or its surface coating agent; and
Fire extinguishers, fire extinguishing agents for fire extinguishers and foam fire extinguishing agents.

Please click here to see the official text of the draft measure in Japanese.

China

China Adds 11 Chemicals to Inventory of Existing Chemical Substances

On December 22^nd 2021, China’s Ministry of Ecology and Environment announced the addition of 11 chemical substances to its Inventory of Existing Chemical Substances, according to the relevant provisions of the Measures for Environmental Management and Registration of New Chemical Substances (Order No. 12) and the Guidelines for Environmental Management and Registration of New Chemical Substances (Announcement No. 51 of 2020). The 11 substances that were added is shown in Table 1 below:

Table 1:

	Chemical name	CAS Number
1	3,4-Dimethyl-benzaldehyde	5973-71-7
2	4-Amino-N-(4-aminophenyl)benzenesulphonamide	16803-97-7
3	4-(Trifluoromethyl)benzoicacid	455-24-3
4	Propanoic acid, 2-hydroxy, C12-13-branched alkyl esters	1471312-26-1
5	N,N’-Carbonyldiimidazole	530-62-1
6	L-Alaninol	2749-11-3
7	Benzyl glycidyl ether	2930-05-4
8	1H-1-Benzazepine-1-aceticacid, 3-amino-2,3,4,5-tetrahydro-2-oxo-,1,1-dimethylethylester,(3S)-	109010-60-8
9	4′-Bromomethyl-biphenyl-2- carboxylic acid tert-butylester	114772-40-6
10	N-Phenyl guanidine	2002-16-6
11	6-Bromo-3-methyl-3H-dibenz[f,ij]isoquinoline-2,7-dione	81-85-6

For more details on the announcement, please click here.

Australia

Australian industrial chemicals

In March, the Australian Government – AICIS published the following updates related to chemicals:

Date	Tittle
7^th March 2022	Importing or exporting mercury Importing or exporting mercury is restricted in Australia under the Minamata Convention on Mercury.
31^st March 2022	Guide to categorising your chemical importation and manufacture
10^th March 2022	Download full list of chemicals on the Inventory
4^th March 2022	Chemicals added to the Inventory 5 years after issue of assessment certificate

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Cosmetics & Personal Care

Protection of hair against odor pollution

Today, the term “Exposome” is used to describe all environmental factors that can have an impact on the skin and its appendages. Solar radiation, air pollution (both outdoor and indoor) and cigarette smoke have long been known to dull the complexion, alter the firmness of the skin, and accelerate the appearance of wrinkles and pigmentary disorders.

In the case of hair, air pollution weakens the hair fibres, and the deposit of particles makes the hair dull and brittle. But another type of consequence can also be mentioned: olfactory pollution. Hair is known to catch odours very easily, whether they are good or bad. After all, who has never complained about having their hair smell like tobacco, fumes or fried food after spending time in "polluted" environments?

To combat these "bad smells", Eurofins Cosmetics & Personal Care has developed a new approach that allows you to evaluate the "anti-odour" effectiveness of hair products (shampoos, conditioners, leave-ins or mists). Hair strands are treated before and after prolonged contact with odourant molecules (chosen according to your needs) and then our expert panel evaluates the neutralising effect of the product on odours in comparison to untreated strands.

New Service: Cleaning Validation Strategy

Avoiding possible residues and contaminants in products is of the utmost importance. The process of cleaning validation is one of the key steps to ensure safe cosmetic products.

Following the cross-contamination control reinforcement, regulatory authorities today require industries such as pharmaceutical, cosmetics, medical devices, etc., to take a risk-based approach for their validation strategy and new acceptance criteria.

With Eurofins, a cleaning validation serves to prove that defined cleaning and disinfection measures of production sites and associated equipment are suitable and sufficient regarding the production of harmless products, following the steps below:

Microbiology testing and consulting
Analytical testing: rinse-water analysis, swab analyses
Audit, consulting: assessment of your cleaning and validation strategies, action plan to fill gaps, a training plan

We can help you to use the same production vessel for different products, ensuring that no particles, residues and contaminants will remain from one production to another.

Expansion of oral care assessment

Measurement and assessment of denture plaque can provide valuable information regarding an individual's oral health status and the assessment of new oral treatments or oral products.

This evaluation involves the use of several oral indices to describe the health status of hard and soft tissues by evaluating the following indices:

Evaluation of the plaque Index (PI)

The effect on the dental plaque is assessed objectively and semi-quantitatively by clinical score using the plaque index Silness & Loe. The Silness & Loe index assesses the thickness of the plaque deposited on the surface of the gingival border of all teeth present in the mouth. Plaque developers are not used; it is determined by passing an explorer over the surface of the tooth and examining the plaque probe tip.

Evaluation of the gingival index (GI)

The gingival index described by Loe & Silness, measures the severity of the inflammatory response around all the teeth present in the mouth by determining the quantity, quality, severity and location. Each tooth is divided into 4 gingival units (vestibular, lingual, distal, and mesial).

Sulcus Bleeding Index (SBI)

The measurements are performed according to the Sulcus Bleeding Index (SBI) described by Muhlemann and Son.

These indices complement an already well-developed clinical offering for the evaluation of oral products:

Teeth Whitening, Anti-Plaque, Anti-Tartar, Teeth Hypersensitivity, Anti-Bacterial (Mouth), Anti-Halitosis.

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Personal Protective Equipment

Europe

Standards 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 ISO 20345:2022	Personal protective equipment - Safety footwear (ISO 20345:2021)	2023-03-31	EN ISO 20345:2011
EN ISO 20346:2022	Personal protective equipment - Protective footwear (ISO 20346:2021)	2023-03-31	EN ISO 20346:2014
EN ISO 20347:2022	Personal protective equipment - Occupational footwear (ISO 20347:2021)	2023-03-31	EN ISO 20347:2012

Product recalls / Alerts

Below you will find a monthly summary of product recalls and alerts in Europe (Source “RAPEX”) and in the U.S. (Source “CPSC).

Europe

RAPEX (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities).

The following 12 alerts regarding Personal Protective equipment were reported between week 51 and week 52 of 2021 and between week 8 and week 16 of 2022.

Type of Risk	Number of alerts	Notes
Health risk / other	9	Particle filter mask The particle/filter retention of the material is insufficient. Furthermore, the physical resistance of the filtering material is too high. It does not comply with the Personal Protective Equipment (PPE) Regulation and with the relevant European standard EN 149.
Injuries	1	Visibility vest The vest does not have a sufficient retroreflective surface. As a result, the user is not sufficiently visible in situations where high visibility is essential. The product does not comply with the Personal Protective Equipment Regulation nor with the European standard EN 1150.
Injuries	2	Helmet The shock-absorbing capacity of the helmet is insufficient and can easily break during an impact, thus not sufficiently protecting the user from injuries to the head. The product does not comply with the Personal Protective Equipment (PPE) Regulation and with the European standard EN 1078.

OPSS issues Product Safety Alerts on the UK market. The following 1 alert regarding Personal protective equipment (PPE) between week 12 and week 16 of 2022.

Type of Risk

Number of alerts

Notes

Injuries

Pulley

It has a risk of breakage that could cause a user to fall. The product does not meet the requirements of the Personal Protective Equipment (Enforcement) Regulations 2018.

Between 21^st January and 20^th April 2022, the CPSC (Consumer Product Safety Commission) published the following 1 recall: 0 recalled PPE products.

Type of Risk

Number of alerts

Notes

Injuries

Helmets

They do not comply with the U.S. CPSC federal safety standard for bicycle helmets.

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Softlines & Leather

Europe

Sustainable products initiative

On 3^rd April 2022, the European Commission opened a public consultation to collect opinions about the adopted act to the Ecodesign Directive on consumer products and to propose additional legislation within the EU market to promote sustainability.

The main aims of the proposal for establishing a framework for Ecodesign requirements for sustainable products and repealing Directive 2009/125/EC, are to reduce the negative life cycle environmental impacts of products and improve the internal market. It also provides for the creation of a digital product passport (‘product passport’), for the setting of mandatory green public procurement criteria and to create a framework to prevent unsold consumer products from being destroyed.

This regulation is part of a package of initiatives presented by the Commission relating to sustainable products and fostering sustainable product choices. The package includes targeted sectoral initiatives on textiles (COM(2022) 141 final), construction products (COM(2022) 144 final.) and a new Circular Economy Action Plan (COM(2020) 98 final).

The main affected products are: electronics & ICT equipment, textiles, furniture, steel, cement & chemicals.

The public consultation is open until 22^nd June 2022.

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

EU Strategy for Sustainable and Circular Textiles

On 30^th March 2022, the European commission published the Communication about EU strategy for sustainable and circular textiles. (COM(2022)141 final).

The aim is that, by 2030, textile products placed on the EU market will be long-lived and recyclable, to a greater extent made of recycled fibres, free of hazardous substances and produced in conditions that respect social rights and the environment. On other hand, the incineration and landfilling of textiles would be reduced to the minimum. Below is a table with the key actions of the European Strategy:

EU Strategy for Sustainable and Circular Textiles
Key actions	Date
Actions under the Ecodesign for Sustainable Products Regulation following its adoption
Mandatory performance requirements for the environmental sustainability of textile products	2024
Digital Product Passport for textiles with information requirements on environmental sustainability	2024
Mandatory requirements concerning green public procurement and Member State incentives	2024
Disclosure of the number of discarded products by large enterprises and their subsequent treatment, and measures on banning the destruction of unsold textiles	2024
Other actions on sustainable production and consumption
Empowering consumers in the green transition and ensuring the reliability of green claims	2022
Review of the Textile Labelling Regulation and considering the introduction of a digital label	2023
Revision of the EU Ecolabel criteria for textiles and footwear	2024
Product Environmental Footprint Category Rules for apparel and footwear	2024
Initiative to address the unintentional release of microplastics from textile products	2022
Review of the Best Available Techniques Reference Document for the Textiles Industry	2022
Enforcing the Corporate Sustainability Due Diligence Directive in the textile sector	As of 2023
Actions on waste challenges
Extended Producer Responsibility requirements for textiles with eco-modulation of fees and measures to promote the waste hierarchy for textile waste	2023
Launch of work on the setting of preparing for re-use and recycling targets for textiles	2022
Enforcing the restrictions on exports of textile waste outside the OECD and developing criteria for distinguishing waste from second-hand textile products	As of 2023
Actions to enable the transition
Launch of the Transition Pathway for the Textiles Ecosystem	2022
Guidance on supporting uptake and partnerships for the circular economy between social enterprises and other actors, including in the textile sector	2022
Guidance on circular economy business models featuring the textile sector	2024
Launch of #ReFashionNow	As of 2022
New European Bauhaus to support sustainable textiles	As of 2022
Horizon Europe calls to support R&D in textiles	2021-2027
Adoption of common industrial technology roadmap on circularity	2022
Criteria for circular manufacturing of apparel under the Taxonomy Regulation	2022
Work on skills for the textiles ecosystem within the European Skills Agenda and the renewed European Alliance for Apprenticeships	As of 2022
Strengthening of market surveillance through cooperation between enforcement authorities and launch of EU Toolbox against counterfeiting	As of 2022

The development of end-of-waste criteria for plastic waste

In the Circular Economy Action plan, the European Commission announced the assessment to identify the priority list of waste streams for the development of further EU-wide end-of-waste criteria. After several years of work, the top two candidate streams to be prioritised are:

Plastics (polyethylene terephthalate recovered/recycled, mixed plastics waste recovered/recycled, polypropylene plastic recovered/recycled from plastic waste between others).
Textiles (cellulosic fibres recovered/recycled and mixed fibres recovered/recycled from textile waste between others).

The development of end-of-waste criteria for plastic waste will commence in Q2 2022 with the finalisation of the technical assessment expected by Q1 2024.

The work on end-of-waste criteria for textile waste will commence in 2023.

For more information, consult the European Commission website here.

France

Technical publications

The latest publications by Anses related to textile and footwear:

Date	Publication
09/03/2022	Chemicals in textiles and footwear: a proposal for regulations that offer more protection

California Designates Treatments Containing PFAS Substances for Use on Converted Textiles or Leathers as a Priority Product

On April 1^st 2022, California’s Department of Toxic Substances Control (DTSC) listed a new Priority Product under the Safer Consumer Products Regulations: treatments containing PFAS substances for use on converted textiles or leathers such as carpets, upholstery, clothing, and shoes. The cover products include aftermarket treatment products, such as cleaners, protectants, spot removers, and water repellents, but does not include products exclusively used during the manufacturing of converted textiles and leathers.

By May 31^st 2022, domestic and foreign manufacturers of the covered products must submit to the DTSC a Priority Product Notification (PPN), naming all of the manufacturer’s products that contain PFAS. Then, by September 28^th 2022, manufacturers must submit one of the following:

a Chemical Removal Intent/Confirmation Notification;
a Product Removal Intent/Confirmation Notification;
a Product-Chemical Replacement Intent/Confirmation Notification; or
a Preliminary Alternatives Analysis Report or other alternate reporting options.

For more information on the PPN, please visit the DTSC’s website here. To see the full text of the new Regulation, please click here.

New Jersey Introduces Bill to Restrict the Use of Recyclable Claims

New Jersey has recently introduced Bill S2145 to prohibit the sale of certain products marketed as recyclable, unless the Department of Environmental Protection determines that the products are widely recycled.

Under Bill S2145, any symbol (such as the chasing arrows symbol or chasing arrows symbol surrounding a resin identification code) or statement claiming the product or packaging is recyclable, or otherwise directing the consumer to recycle the product or packaging, will be considered a deceptive or misleading claim unless the product or packaging is considered recyclable in New Jersey and is of a material type and form that routinely becomes feedstock used in the production of new products or packaging.

California Proposition 65 60-Day Notices for BPA in Shoes

In April 2022, there have been several Proposition 65 60-day notices for Bisphenol-A (BPA) in shoes. BPA is listed under Proposition 65 as a chemical known to cause reproductive toxicity.

Please click here to view the 60-day notices for BPA in shoes that have been published thus far.

Canada

Canada Updates Product Safety Laboratory Test Methods

Chemistry Methods

Determination of Leachable Arsenic (As), Selenium (Se), Cadmium (Cd), Antimony (Sb), and Barium (Ba) in Applied Coatings (C03)
Determination of para-Phenylenediamine (PPD) in cosmetics and similar consumer products by GC-MS (C42)

Flammability Methods

Flammability of textiles (F01)

Mechanical Methods

Sharp Edges (M00.2)
Flexible Film Bags (M03)
Playpens (M08)
Cradles (M12.2)

For a full list of the PSL test methods, please click here.

China

China Issues New Standard for Ski and Snowboard Wear

China has released a new national standard GB/T 41176-2021 Professional sportswear – ski and snowboard wear, which will become effective on July 1^st 2023.

For more information regarding the new national standard, please click here.

Morocco

New requirements for textile items

In March, the Ministry of Industry and Trade of Morocco published a notice for importers which indicates the new requirements for textiles items. The main points are:

Clothing fabrics are included in the list of items subject to control at origin. There is a transition period until 07/05/2022 for importers not provided with COCs to submit these clothing fabrics to Morocco for inspection.
From 07/04/2022 no derogation will be granted. The Certificate of compliance (COC) is mandatory, if the items are on the list of control at origin products.
The conformity assessment of products found to be non-compliant following the first inspection by sample can be the subject of a 2nd analysis at the request of the importer.

Goods that do not comply with the requirements will not be authorised to enter the market.

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Toys, Childcare & Hardlines

Europe

Comments about the General product safety Regulation proposal

On 4^th March 2022, the European Commission published the opinion of the European Economic and Social Committee on the proposal for a regulation by the European Parliament and of the Council on general product safety.

The proposed regulation aims to update the rules currently set out in Directive 2001/95/EC to ensure a safety net for all products and, at the same time, to ensure that the regime provides greater consistency by aligning market surveillance rules for products falling outside the scope of the EU harmonisation legislation (‘non-harmonised products’) with those applying to products falling under the scope of the EU harmonisation legislation (‘harmonised products’) as set out in Regulation (EU) 2019/1020 of the European Parliament and of the Council.

It will also amend Regulation (EU) No 1025/2012 and repeal Council Directive 87/357/EEC and Directive 2001/95/EC of the European Parliament and of the Council.

For more information, consult the official publication here.

France

New approved eco-organizations

On 24^th February 2022, the French authorities approved several eco-organisation for DIY and garden items and mineral or synthetic, lubricating or industrial oils according to the principle of extended producer responsibility (REP) defined in the environmental code.

REP aims to transfer responsibility of residual materials generated by the consumption of products to the companies that market them on a national territory.

In this case, in France, producers must join an approved eco-organisation to fulfil their obligations.

Technical publications

The latest publications by several French entities related to consumer products and the environment:

Date

Entity

Publication

March 2022

DGCCRF (Direction générale de la concurrence, de la consommation et de la répression des fraudes)

"CE" marking: for peace of mind in shopping

The “CE” marking appears on the majority of non-food products. It materialises the product manufacturer's commitment to its compliance with the requirements set by community regulations. It must be affixed before a product is placed on the European market.

The official publication can be seen here in French.

March 2022

DGCCRF (Direction générale de la concurrence, de la consommation et de la répression des fraudes)

Control of new feminine hygiene products

In 2021, the DGCCRF continued its action to monitor feminine hygiene products, adapting to changes in this market and focusing controls on reusable pads or menstrual panties and on so-called "biological" single-use tampons. or reusable.

The official publication can be seen here in French.

FDA Issues Guidance on Initiation of Voluntary Recalls

On March 4^th 2022, the Food and Drug Administration (FDA) published in the Federal Register the following notification of availability of a guidance for industry and FDA staff entitled “Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C” (the “Guidance”).

Initiation of Voluntary Recalls; Guidance for Industry and Food and Drug Administration Staff; Availability

The Guidance discusses the following topics related to voluntary recalls:

Preparations that firms in a distribution chain, including manufacturers and distributors, should consider making to:
- establish recall initiation procedures;
- ensure timely identification of product issues that might lead to a recall;
- promptly issue recall communications and press releases; and
- ensure timely responses to a recall communication.
How the FDA assists firms with carrying out their recall responsibilities to protect public health from products in violation of the Food, Drug, and Cosmetic Act and other FDA laws.

For more details of the Guidance, please visit the following link: https://www.fda.gov/media/123664/download

New Jersey Introduces Bill to Restrict the Use of Recyclable Claims

FCC Expands List of Communications Equipment and Services that Pose a National Security Threat

On March 25^th 2022, the Federal Communications Commission (FCC) announced the addition of equipment and services from 3 entities (AO Kaspersky Lab, China Telecom (Americas) Corp, and China Mobile International USA Inc.) to its list of communications equipment and services that have been deemed a threat to national security. The Secure and Trusted Communications Networks Act requires the FCC to maintain a list of communications equipment and services that pose an unacceptable risk to national security or the security and safety of the US people.

For a view of the full list, please click here.

Canada

Comments on the Consultation of RSS-236, Issue 2 “General Radio Service Equipment Operating in the Band 26.960 MHz to 27.410 MHz (Citizens Band)”

Canada’s Department of Innovation, Science and Economic Development is requesting comments on the consultation of RSS-236, issue 2, “General Radio Service Equipment Operating in the Band 26.960 MHz to 27.410 MHz (Citizens Band)” no later than May 17^th 2022. This Radio Standards Specification (RSS) provides the general requirements on the certification of radio apparatus that is used for the Citizens Band.

In order to download the draft RSS-236, issue 2, please visit the Radio Advisory Board of Canada’s website here.

Canada’s ISED Amends RSS-119, Land Mobile and Fixed Equipment Operating in the Frequency Range 27.41-960 MHz

On April 1^st 2022, Canada’s Department of Innovation, Science and Economic Development (ISED) amended RSS-119, Land Mobile and Fixed Equipment Operating in the Frequency Range 27.41-960 MHz. The following changes were made in the amended RSS:

The RSS-125 reference in Section 1.1 was updated to reflect the new frequency band and the new document title
The references to TIA-603 were removed because the TIA-603 requirements are now included in ANSI C63.26.

For more information, please visit the Government of Canada’s website here.

China

China Approves New Substances Safe for Food Contact

On February 24^th 2022, China’s National Health Commission issued an announcement on the approval of new additives and materials safe for food contact use. Please see Table 1 below for a summary of the updates.

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/GBR/47

United Kingdom

The Toys and Cosmetic Products (Restriction of Chemical Substances) Regulations 2022

They will amend the Toy Regulations, to reduce the permitted limits of aluminium, aniline and formaldehyde as well as including provisions on three allergens used in fragrances, under the list of prohibited allergens in toys.

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COVID-19 | Testing, inspection and certification of products and devices

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More information on this global service offer is available here.

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