Eurofins | Newsflash - December 2018 | Chemicals

Europe - REACH

Recent Updates Regarding REACH

Below table includes a summary of the main recent updates (non-exhaustive) regarding REACH Regulation (EC) No 1907/2006:

Summary of main recent updates
Date	Subject	Link
October -November 2018	New substances evaluation conclusions published: 2,4,6-tri-tert-butylphenol (EC 211-989-5; CAS 732-26-3) by Belgium Trade name: WÄSSERIGE LOESUNG DES MV31-KALIUMSALZ (EC 444-340-1; CAS -) by Germany N,N-dicyclohexylbenzothiazole-2-sulphenamide ( EC 225-625-8; CAS 4979-32-2) by Germany Dipotassium tetraborate (EC 215-575-5; CAS 1332-77-0) by Lithuania 2,4,6-trichloro-1,3,5-triazine (EC 203-614-9; CAS 108-77-0) by Poland	Click here for getting the published evaluation document in ECHA’s website.
October –November 2018	European Chemicals Agency’s updated FAQs on Brexit.	ECHA’s Advice to companies / Q&As here.
14^th November 2018	New web pages to prepare companies for UK’s withdrawal from EU.	More information here.
31^st October 2018	The submission of the Annex XV restriction report on oxo-degradable plastics by ECHA has been postponed until 19 July 2019.	Registry of restriction intentions here.

Europe - CLP

Recent Updates Regarding CLP

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

Summary of main recent updates
Date	Subject	Link
November 2018	Public consultation on harmonised classification and labelling: Emamectin benzoate (ISO); (4’’R)-4’’-deoxy-4’’ (methylamino)avermectin B1 benzoate (EC -; CAS 155569-91-8) Trinexapac-ethyl (ISO); ethyl 4-[cyclopropyl (hydroxy) methylene]-3,5-dioxocyclohexanecarboxylate; ethyl (1RS, 4EZ)-4-[cyclopropyl(hydroxy)methylene]-3,5-dioxocyclohexanecarboxylate (EC -; CAS 95266-40-3) [S-(Z,E)]-5-(1-hydroxy-2,6,6-trimethyl-4-oxocyclohex-2-en-1-yl)-3-methylpenta-2,4-dienoic acid; S-abscisic acid (EC 244-319-5; CAS 21293-29-8) The deadline for comments is 11 January 2019.	Public consultation on harmonised classification and labelling here.
November 2018	Public consultation on harmonised classification and labelling: Methyl salicylate (EC 204-317-7; CAS 119-36-8) 4-methylpentan-2-one; isobutyl methyl ketone (EC 203-550-1; CAS 108-10-1) The deadline for comments is 25 January 2019.	Public consultation on harmonised classification and labelling here.
November 2018	Proposals to harmonise classification and labelling for: Methyl salicylate ( EC 204-317-7 ; CAS 119-36-8) tritosulfuron (ISO) (containing ≤ 0.02 % 2-amino-4-methoxy-6-(trifluormethyl)-1,3,5-triazine); 1-[4-methoxy-6-(trifluoromethyl)-1,3,5-triazin-2-yl]-3-[2-(trifluoromethyl)benzenesulfonyl]urea (containing ≤ 0.02 % 2-amino-4-methoxy-6-(trifluormethyl)-1,3,5-triazine) (EC 604-291-0; CAS 142469-14-5) Intentions to harmonise the classification and labelling for: dibutyltin di(acetate) [1]; dibutyltin bis(2-ethylhexanoate) [2] (EC -, CAS -)	Click here for the Registry of CLH intentions until outcome.

Europe

Adoption of Proposal for Directive to reduce use of certain plastic products

On 24^th November, the European Parliament adopted the proposal directive on the reduction of the impact of certain plastic products on the environment that was published on 28^th May (2018/0172(COD)). Within other requirements, this Directive will ban items such as disposable plastic plates, cutlery, plastic straws and cotton swabs by 2021.

Some other examples (not exhaustive) of single-use plastic items that will have specific requirements as foreseen in this Commission’s proposal:

Food containers
Cups for beverages
Sticks for balloons
Packets and wrappers
Beverage containers
Sanitary items (wet wiped, sanitary towels)

Click here for getting the European Parliament report.

Click here for getting the news from News European Parliament.

Europe

Report about substances with endocrine-disrupting properties

On 7^th November 2018, the European Commission published the report “COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Towards a comprehensive European Union framework on endocrine disruptors”.

Click here for getting the report from European Commission website.

Europe

New proposal amendments for RoHS

The European Commission has recently published the following proposal amendments to Directive 2011/65/EU (RoHS) as below:

Reference	Title
C/2018/7495	COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for cadmium and its compounds in electrical contacts.
C/2018/7499	COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages.
C/2018/7505	COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as activator in the fluorescent powder of discharge lamps containing phosphors.
C/2018/7506	COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in bearings and bushes applied in certain non-road professional use equipment.
C/2018/7507	COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead and cadmium in printing inks for the application of enamels on glasses.
C/2018/7508	COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead bound in crystal glass as defined in Directive 69/493/EEC.
C/2018/7509	COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in PZT based dielectric ceramic materials for certain capacitors.
C/2018/7520	COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in dielectric ceramic in certain capacitors.
C/2018/7523	COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in the plating layer of certain diodes.
C/2018/7525	COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead oxide in seal frit used for making window assemblies for certain laser tubes.

Brexit: chemical regulation

On 7^th November 2018, the House of Lords EU Energy and Environment Sub-Committee published its report on chemical regulations after Brexit and, in September, the UK Government issued its recommendations in case there is no agreement on Brexit.

Click here for getting the official publication from Parliament UK’s website.

Click here for getting the official publication from UK Government’s website.

France

Ban of single-use plastics items

The French authorities are working to reduce plastic litter in the ocean with the application of different Acts within the next year, as well as others that had already been implemented in previous years.

Disposable plastic cups, glasses and plates will be banned from 1 January 2020 (see art.73 of the Energy Transition for Green Growth Act 2015-992 and Decree 2016-1170).

Cotton swabs for domestic use with plastic stem will be prohibited from January 1, 2020 (art.124 of the Law of August 8, 2016 called law "Biodiversity"). It is the same article of this law which provides for the prohibition, since 1 January 2018, of the sale of rinse-off cosmetic products for exfoliating or cleaning use containing solid plastic particles.

Click here for getting the publication in Service-Public.fr website.

Click here for reading the article in Le portail de l’Économie, des Finances de l’Action et des Comptes publics.

Germany

New German packaging Act

On January 2019 the new German Packaging Act (VerpackG) will enter into force with the aim to improve the current law. This new law is focusing on recycling and in the prevention of packaging waste.
This legislation applies to all manufacturers, importers, distributors and retailers that place products in the German market and they shall register in the Central Packaging Registry at www.verpackungsregister.org.

Regulatory updates

Below a summary table with some recent US proposals notified to World Trade Organization (WTO) on Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances which were the subject of premanufacture notices (PMNs).

Notification number	Date	Title
G/TBT/N/USA/1399	22/10/2018	Significant New Use Rules on Certain Chemical Substances ( 28 chemical substances).
G/TBT/N/USA/1401	23/10/2018	Significant New Use Rules on Certain Chemical Substances (13 chemical substances).
G/TBT/N/USA/1428	20/11/2018	Significant New Use Rules on Certain Chemical Substances (66 chemical substances).

CPSC Recalls Products for Violation of Poison Prevention Packaging Act

Recently, the Consumer Product Safety Commission issued two recalls for failure to meet child resistant closure requirement under Poison Prevention Packaging Act (PPPA).

The PPPA, enacted in 1970, requires packaging of household substances to be designed or constructed to be significantly difficult for children under five years of age to open within a reasonable time, and not difficult for normal adults to use properly.

The increased recalls for such cases indicate that the Commission is strengthening the enforcement of PPPA requirements and stakeholders shall pay more attention to this trend and make sure the packaging of their products meet PPPA requirements (if under the scope).

EPA Proposes Technical Amendments for Composite Wood Emission Standards

On 1^st November 2018, the US Environmental Protection Agency (EPA) published a proposed rule in the Federal Register to amend several technical requirements in the final formaldehyde rule for composite wood products.
Comparing to the final composite wood emission standards published on December 12, 2016, the proposed rule would align more with the CARB's ATCM Phase II program.

Comments were due by December 3, 2018. For more information click here.

US - California

California Proposition 65 Reformulations (December, 2018)

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 implement of California Proposition 65, more and more court cases are 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 agreement are summarized as below:

Product	Chemical	Limit	Case No
Hat	DINP	1000ppm Products exceed the limit shall utilize a warning statement.	Out of court

US - California

Nickel (Soluble Compounds) Effectively Added to the California Proposition 65 List

On 26^th October 2018, Nickel (soluble compounds) was effectively added to the list of chemicals known to the state to cause reproductive toxicity under California Proposition 65.

Based on the consideration of the Developmental and Reproductive Toxicant Identification Committee (DARTIC) in a public meeting on October 11, 2018, the Office of Environmental Health Hazard Assessment (OEHHA) added this chemical to the list, summary can be found below:

Chemical	CAS No.	Toxicological Endpoints	Listing Mechanism
Nickel (soluble compounds)	---	Male Reproductive Toxicity Developmental Toxicity	SQE

Soluble Nickel's addition to the Prop 65 list was effective October 26, and the warning requirement for this listing will become effective in one year.

Canada

Carcinogenicity potential from 7 colorant ingredients

On 3^rd November, the Government of Canada published a draft screening assessment of seven Anthraquinones substances with carcinogenicity potential.

Theses 7 substances are:

Solvent violet 13
Pigment blue 60
Solvent violet 59
Solvent blue 36
Disperse red 60
Acid blue 239
9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl", including methyl- and pentyl- derivatives

Click here for getting the Draft screening assessment Anthraquinones group.

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