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Eurofins >> Consumer Product Testing >> Media Centre >> News >> Chemicals | Monthly bulletin | May 2020

Chemicals | Monthly bulletin | May 2020

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Eurofins newsflash Chemical

 

Regulatory news

 


 

Europe

 

European actions against the shortage of disinfectants

 

The European Chemical Agency (ECHA), together with the European Commission, will support Member States and industry to address shortages of the supply of disinfectants, which has become a critical issue for several EU Member States.

 

The ECHA will extend some of its deadlines to help chemical companies and is supporting EU/EEA authorities to apply Exceptions to the normal authorisation requirements for biocidal products.

 

For more information, please visit the ECHA‘s website here.

 

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

23/03/2020

Publication of the substance evaluation draft decisions on registrants’ comments (CoRAP 2019 batch, 31 substances)

Substance evaluation draft decisions here

25/03/2020

Publication of consultation launched on the proposed restriction of:

 

Consultation is open from 25 March to 25 September 2020. ECHA’s scientific committees welcome early comments by 13 May 2020 to assist them in the first discussion of the proposal in June 2020

 

The deadline for comments is 25 May 2020

Submitted restrictions under consideration here

01/04/2020

Newest Hot topics page:

 

Visit the ECHA’s website here

01/04/2020

The opinions of the Committee for Risk Assessment in relation to:

 

Registry of restriction intentions until outcome found here

01/04/2020

New substance evaluation conclusions published

 

For more information, visit ECHA’s website here

01/04/2020

The deadline for companies to submit their data in ePIC on exports and imports of chemicals under the PIC Regulation has been extended from 31 March 2020 to 31 May 2020. The extension was decided upon to take into consideration the current COVID-19 pandemic

Annual reporting on PIC exports and imports consultations can be viewed here

15/04/2020

Delayed the submission of ECHA Annex XV restriction report on three lead chromate substances in articles. This is due to ongoing discussions about the restriction of lead stabilisers in PVC, which were blocked by the European Parliament in February and the pending court case in relation to authorising the use of lead-based pigments, initiated by the Swedish government and appealed by the Commission

Registry of restriction intentions until outcome found here

 

Recent Updates Regarding CLP

 

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

 

Summary of the Most Recent Update

Date

Subject

Link

25/03/2020

Consultation on harmonised classification and labelling:

 

The deadline for comments is 22 May 2020

 

  • Mepiquat chloride (ISO); 1,1-dimethylpiperidinium chloride (EC 246-147-6, CAS 24307-26-4)
  • Difenoconazole (ISO); 1-({2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-yl}methyl)-1H-1,2,4-triazole; 3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether (EC 601-613-1 CAS 119446-68-3). The draft assessment report is available on EFSA's website

The deadline for comments is 1 June 2020

 

Harmonised classification and labelling consultations can be viewed here

15/04/2020

New intention to harmonise classification and labelling for

 

Registry of CLH intentions until outcome can be viewed here

 

Fitness checks of EU legislation in relation to endocrine disrupting chemicals (EDCs)

 

On 21st March 2020, the European Commission published the following report:

 

Targeted Stakeholder Consultation in the context of a Fitness Check of the EU legislation with regard to Endocrine Disruptors - Factual Summary Report

 

This report provides opinions about the endocrine disrupting chemicals (EDC) consultation which collected views on effectiveness, efficiencies and possible legislative incoherencies of European legislation and possible impacts on stakeholders.

 

The main conclusion is that survey respondents find the current lack of harmonised criteria problematic, and view the current legislation as not protecting human health and the environment.

 

Technical publicactions

 

Please find below a table summarising the most recent technical publications on food contact materials (non-exhaustive):

 

Date

Countries

Entity

Title

24/03/2020

Europe

European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC)

Applicability of Analytical Tools, Test Methods and Models for Polymer Risk Assessment

 

Second report of ECETOC trilogy on polymer safety assessment looks at analytical tools, methods and models

17/02/2020

Holland

Dutch National Institute for Public Health and the Environment (RIVM)

Plastic Pact Nederland : de Monitor Nulmeting (2017-2018)

 

This is the first report which outlines recycling potential and the use of recycled plastics in the years 2017 and 2018. These findings will serve as the baseline measurements from which the Dutch plastic pact’s goals, to be achieved by the year 2025, will be set

 

US

 

The use of PFAS in food packaging and containers

 

Currently the concern about per- and polyfluoroalkyl substances (PFAS) continues to grow due, in part, to their prevalence in the environment. In U.S., several states have taken actions to limit or ban their use often in food packaging. Please find below a table summarising bills introduced or progressed since the beginning of the year in relation to PFASs.

 

 

State

Bill code

Title

Description

Arizona

SB 1468

Food Packaging: Prohibitions

Prohibits the manufacture and sale of food packaging containing PFAS and/or phthalates. It would be effective January 1, 2023

Connecticut

H.B. 5291

An Act Limiting the Use of Perfluoroalkyl and Polyfluoroalkyl Substances and Expanded Polystyrene in Food Packaging

Prohibits the manufacture and sale of food packaging containing PFAS if reasonable alternatives exist. It would be effective January 2022

Illinois

SB 3154

PFAS Reduction Act

Prohibits manufacture and sale of firefighting foam containing PFAS, prohibits use of PFAS foam for training purposes, prohibits the manufacture and sale of food packaging containing PFAS. It would be effective January 1, 2021

New Hampshire

HB 1425

 

Requires removal of all containers containing PFAS from schools and hospitals

Massachusetts

HD 3839

An Act to Ban the Use of PFAS in Food Packaging

The legislation would ban the manufacture and sale of food packaging to which PFASs had been intentionally added in any amount

Minnesota

SF 3225

Perfluoroalkyl substances (PFAS) use in food packaging regulation

Prohibits the manufacture and sale of food packaging containing PFAS. It would be effective January 1, 2021

New Jersey

A3350

An Act concerning the use of perfluoroalkyl and polyfluoroalkyl substances in food packaging

Food packaging containing a PFAS chemical would be banned 18 months after DEP determines that a safer alternative is available and publishes its findings in the New Jersey Register

New York

S2000B

An Act to amend the environmental conservation law, in relation to the use of perfluoroalkyl and polyfluoroalkyl substances in food packaging

It would be effective December 31, 2021

Rhode Island

H 7307

An Act Relating to Health and Safety – PFAS in Food Packaging

Prohibits the use of PFAS in food packaging materials. It would be effective January 1, 2021

Virginia

HB 1712

Food Packaging; PFAS chemicals, penalty

Prohibits the sale of food packaging containing PFAS

Wisconsin

 AB 952

An Act relating to regulating certain chemicals in food packaging

Prohibits the manufacture and sale of food packaging containing PFAS if reasonable alternatives exist. It would be effective January 1, 2023

Others

Bill code

Title

Description

S.3227

Prevent Future American Sickness Act

It includes bans on use of PFAS in food packaging and containers. It would become effective January 1, 2022

S.1790

National Defense Authorization Act for Fiscal Year 2020

It prohibits the use of PFAS in food packaging for military ready-to-eat meals (MREs) after October 1, 2021

 

Risk Evaluation under TSCA

 

On 20th February 2020, United States Environmental Protection Agency (EPA) published the list of 20 Low-Priority chemical substances under the Toxic Substances Control Act (TSCA).

 

Chemical Name

CAS

1-Butanol, 3-methoxy-, 1-acetate

4435-53-4

D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)-

31138-65-5

D-Gluconic acid

526-95-4

D-Gluconic acid, calcium salt (2:1)

299-28-5

D-Gluconic acid, .delta.-lactone

90-80-2

D-Gluconic acid, potassium salt (1:1)

299-27-4

D-Gluconic acid, sodium salt (1:1)

527-07-1

Decanedioic acid, 1,10-dibutyl ester

109-43-3

1-Docosanol

661-19-8

1-Eicosanol

629-96-9

1,2-Hexanediol

6920-22-5

1-Octadecanol

112-92-5

Propanol, [2-(2-butoxymethylethoxy)methylethoxy]-

55934-93-5

Propanedioic acid, 1,3-diethyl ester

105-53-3

Propanedioic acid, 1,3-dimethyl ester

108-59-8

Propanol, 1(or 2)-(2-methoxymethylethoxy)-, acetate

88917-22-0

Propanol, [(1-methyl-1,2-ethanediyl)bis(oxy)]bis-

24800-44-0

2-Propanol, 1,1'-oxybis-

110-98-5

Propanol, oxybis-

25265-71-8

Tetracosane, 2,6,10,15,19,23-hexamethyl-

111-01-3

 

In April 2020, the EPA announced the availability of the draft scope documents for risk evaluations required to be conducted for 20 high-priority chemicals.

 

Chemical Name

CAS

 Chemical Group

Docket Number(s)

p-Dichlorobenzene

106-46-7

N/A

EPA-HQ-OPPT-2018-0446

1,2-Dichloroethane

107-06-2

Solvents

EPA-HQ-OPPT-2018-0427

trans-1,2- Dichloroethylene

156-60-5

Solvents

EPA-HQ-OPPT-2018-0465

o-Dichlorobenzene

95-50-1

N/A

EPA-HQ-OPPT-2018-0444

1,1,2-Trichloroethane

79-00-5

Solvents

EPA-HQ-OPPT-2018-0421

1,2-Dichloropropane

78-87-5

Solvents

EPA-HQ-OPPT-2018-0428

1,1-Dichloroethane

75-34-3

Solvents

EPA-HQ-OPPT-2018-0426

Dibutyl phthalate (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester)

84-74-2

Phthalates

EPA-HQ-OPPT-2018-0503

Butyl benzyl phthalate - 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester

85-68-7

Phthalates

EPA-HQ-OPPT-2018-0501

Di-ethylhexyl phthalate - (1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester)

117-81-7

Phthalates

EPA-HQ-OPPT-2018-0433

Di-isobutyl phthalate - (1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester)

84-69-5

Phthalates

EPA-HQ-OPPT-2018-0434

Dicyclohexyl phthalate

84-61-7

Phthalates

EPA-HQ-OPPT-2018-0504

4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)

79-94-7

Flame retardants

EPA-HQ-OPPT-2018-0462

Tris(2-chloroethyl) phosphate (TCEP)

115-96-8

Flame retardants

EPA-HQ-OPPT-2018-0476

Phosphoric acid, triphenyl ester (TPP)

115-86-6

Flame retardants

EPA-HQ-OPPT-2018-0458

Ethylene dibromide

106-93-4

N/A

EPA-HQ-OPPT-2018-0488

1,3-Butadiene

106-99-0

N/A

EPA-HQ-OPPT-2018-0451

1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB)

1222-05-5

Fragrance additives

EPA-HQ-OPPT-2018-0430

Formaldehyde

50-00-0

N/A

EPA-HQ-OPPT-2018-0438

Phthalic anhydride

85-44-9

N/A

EPA-HQ-OPPT-2018-0459

 

The complete list of Chemicals Undergoing Risk Evaluation under TSCA can be found here.

 

International

 

Regulatory proposals notified to WTO

 

Please see the below table summarising the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):

 

Notification number / Link

Country

Title

G/TBT/N/CHN/1417

China

National Standard of the P.R.C., Polyaluminium Chloride for Treatment of Drinking Water

 

This standard specifies the requirements, test methods, inspection rules, marks, packaging, transportation and storage of polyaluminium chloride for the treatment of drinking water. This standard is applicable to polyaluminium chloride for the treatment of drinking water, which is mainly used for purification of drinking water

G/TBT/N/EU/709

Europe

Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards substances in tattoo inks or permanent make-up

 

This draft regulation relates to a new entry of Annex XVII to Regulation (EC) No 1907/2006. It would restrict the placing on the market and the use of certain substances in mixtures for use for tattooing purposes

G/TBT/N/JPN/658

Japan

Amendment to the Poisonous and Deleterious Substances Designation Order

 

Under the provision of the Poisonous and Deleterious Substances Control Act, Ministry of Health, Labour and Welfare designates 2 substances as poisonous and 14 substances as deleterious

G/TBT/N/KOR/881

Korea

Amendments to the notification of items of waste subject to the Act on the transboundary movement of hazardous wastes and their disposal.

 

We are trying to delete the exemption of waste export and import declaration for those who want to import and export waste paper that is contaminated with oil or contains foreign substances

G/TBT/N/PHL/231

Philipines

Implementing Guidelines for Administrative Order No. 2019-0019 "Repeal of Administrative Order No. 2015-0038 dated 08 September 2015 Entitled Removing the Requirements of Licensing as Importers, Exporters, Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products"

 

Its aims to establish guidelines on the licensing and inspection of HUHS establishments, update the HUHS classification and ensure compliance of HUHS establishments and products with FDA regulatory standards

G/TBT/N/PHL/232

Philipines

New Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration and Other Authorizations and Regulatory Services, Amending Administrative Order No. 50 s. 2001, "Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs"

 

Provides guidelines on fees and charges on FDA services including those processes/services in issuing licenses and product market authorisations on all health products prior to manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship

G/TBT/N/USA/1591

US

Significant New Use Rules on Certain Chemical Substances

 

The EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances which are the subject of premanufacture notices (PMNs) and microorganisms that were subject to a Microbial Commercial Activity Notice (MCAN)

G/TBT/N/USA/1592

US

Protection of Stratospheric Ozone: Adjustments to the Allowance System for Controlling HCFC Production and Import, 2020-2029; and Other Updates

 

These updates include revising the labeling requirements for containers of specific hydrochlorofluorocarbons, clarifications to the certification requirements for methyl bromide quarantine and preshipment uses between other points. The EPA is also adding polyurethane foam systems containing ozone-depleting chlorofluorocarbons to the list of nonessential products. Lastly, the Agency is updating the definition of "destruction" as it is used in the context of the production and consumption phaseout and removing obsolete provisions