Chemicals | Monthly bulletin | May 2022

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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