Eurofins | April 2019 regulatory Newsflash compilation | Chemicals

Europe

ECHA’s active projects for 2019

Some relevant ECHA’s active projects this year.

Standards Updates

Below a summary table with some recent standards updates and upcoming dates of withdrawal and/or availability (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(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.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 availability: date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat.

Reference	Title	*Date of Withdrawal ()**	Supersedes
EN 16402:2019	Paints and varnishes - Assessment of emissions of substances from coatings into indoor air - Sampling, conditioning and testing.	2019-08-31	EN 16402:2013
Reference	Title	*Date of Availability ()**	Supersedes
CEN/TR 13695-2:2019	Packaging - Requirements for measuring and verifying the four heavy metals and other dangerous substances present in packaging, and their release into the environment - Part 2: Requirements for measuring and verifying dangerous substances present in packaging, and their release into the environment.	2019-02-13	CEN/TR 13695-2:2004

New amendment for export and import of hazardous chemicals

On 27^th February 2019, the European Commission published the Commission Delegated Regulation (EU) 2019/330 of 11 December 2018 amending Annexes I and V to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals.

This amendment indicates new chemicals added, deleted and replaced in the List of chemicals subject to export notification procedure (Annex I) and Chemicals and articles subject to export ban (Annex V of Regulation (EU) No 649/2012).

For more information regarding how to notify PIC exports to the UK after UK’s withdrawal from the EU click here.

Click here for getting the European Commission official publication with reference C/2018/8376.

RoHS update

On 5^th February 2019, the following RoHS amendment was published in the Official Journal of the European Union:

COMMISSION DELEGATED DIRECTIVE (EU) 2019/173 of 16 November 2018 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.

Microplastics in the textile industry – Cross Industry Agreement developments

One of the current hot topics is microplastics pollution and how it can affect the environment and human health.

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Deadline for comments on phthalates to update Annex XIV to REACH

12^th March 2019 was the deadline for comments for draft recommendation on four phthalates and their endocrine disrupting properties by ECHA (European Chemical Agency).

The aim is to update Annex XIV (Authorisation List) to REACH Regulation (EC) No 1907/2006 concerning the following four phthalates to include their endocrine disrupting properties:

Bis (2-ethylhexyl) phthalate (DEHP No. CE204-211-0, CAS No. 117-81-7)
Dibutylphthalate (DBP, EC No. 201-557-4, CAS No. 84-74-2)
Benzylbutylphthalate (BBP, CE No. 201-622-7, CAS No. 85-68-7)
Diisobutylphthalate (DIBP, no. CE201-553-2, CAS84-69-5)

Some previously exempted uses may require an application for authorization following this update of Annex XIV. The public consultation targets, in particular, the operators concerned by these uses, namely: use in mixtures between 0.1 and 0.3%, use in materials in contact with foodstuffs or in medical devices.

Recent Updates Regarding REACH

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

Summary of main recent updates
Date	Subject	Link
February 2019	COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document COMMISSION REGULATION (EU) amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances.	Click here for getting the official publication.
March 2019	Judgment of the General Court (Fifth Chamber) of 7 March 2019. Kingdom of Sweden v European Commission. REACH - Commission Decision authorizing the use of lead sulfochromate yellow and chromate red, molybdate and lead sulphate - Article 60 (4) and (5) of Regulation (EC) No 1907/2006 - Examination of the unavailability of alternatives - Error of law.	Click here for more information. DCC Autorisation decision final.pdf
March 2019	Proposal of new substances of very high concern (SVHCs): 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof) (EC -, CAS -) 2-methoxy ethyl acetate (EC 203-772-9, CAS 110-49-6) Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥0.1 % w/w of 4-nonylphenol, branched and linear (4-NP) (EC -, CAS -) The deadline for comments is 29 April 2019.	Click here for more information.
March 2019	Published the update on the Community rolling action plan (CoRAP) covering years 2019, 2020 and 2021 . For this year, 2019, 31 substances will be evaluated and it is planned to get until 100 substances for 2021.	Click here for more information.
March 2019	The Committee for Socio-Economic Analysis (SEAC) adopts its final opinion supporting the proposal to restrict hazardous chemicals in tattoo inks and permanent make-up. The Committee for Risk Assessment (RAC) concludes on sixteen opinions on harmonised classification and labelling.	Click here for more information.
March 2019	Public consultations on restriction proposals: microplastics (EC -, CAS -) formaldehyde and formaldehyde releasers (EC -, CAS -) octamethylcyclotetrasiloxane (D4) (EC 209-136-7, CAS 556-67-2), decamethylcyclopentasiloxane (D5) (EC 208-764-9, CAS 541-02-6) and dodecamethylcyclohexasiloxane (D6) (EC 208-762-8, CAS 540-97-6) The deadline for comments is 20 September 2019.	Click here for Submitted restrictions under consideration.
March 2019	Substance evaluation conclusion published: phenol paraalkylation products with C10-15 branched olefins (C12 rich) derived from propene oligomerization, carbonates, calcium salts, overbased, sulfurized including distillates (petroleum), hydrotreated, solvent-refined, solvent dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50 (EC 701-251-5, CAS-) Evaluated by the Netherlands.	Click here for Substance evaluation - CoRAP.

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

February 2019

Public consultation on the harmonised classification and labelling:

The deadline for comments for the following substances is 3^rd May 2019:

Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica; pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide ( EC 272-697-1, CAS 68909-20-6)
3-methylpyrazole (EC 215-925-7, CAS 1453-58-3)

The deadline for comments for the following substances is 17^th May 2019:

Beta-cyfluthrin (ISO); reaction mass of rel-(R)-cyano(4-fluoro-3-phenoxyphenyl)methyl (1S,3S)-3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane-1-carboxylate and rel-(R)-cyano(4-fluoro-3-phenoxyphenyl)methyl (1S,3R)-3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane-1-carboxylate. (EC -, CAS 1820573-27-0)
Cyfluthrin (ISO); α-cyano-4-fluoro-3-phenoxybenzyl 3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate. (EC 269-855-7, CAS 68359-37-5)
Imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid. (EC -, CAS 114311-32-9)
Pyridalyl (ISO); 2,6-dichloro-4-(3,3-dichloroallyloxy)phenyl 3-[5-(trifluoromethyl)-2-pyridyloxy]propyl ether. (EC -, CAS 179101-81-6)

The deadline for comments for the following substances is 31^st May 2019:

2,4,6-tri-tert-butylphenol; [1] Reaction mass of 2,6-di-tert-butylphenol and 2,4,6-tri-tert-butylphenol; [2] Reaction mass of 2-tert-butylphenol and 2,6-di-tert-butylphenol and 2,4,6-tri-tert-butylphenol [3]. (EC 211-989-5, CAS 732-26-3)
1,4-dimethylnaphthalene. (EC 209-335-9, CAS 571-58-4)

Public consultation on harmonised classification and labelling here.

Final version of guidance on poison centres notifications- CLP

From 5^th March 2019 the Guidance on harmonised information relating to emergency health response – Annex VIII to CLP is available in ECHA’s website.

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US | New York

Bill proposal for electrical cords containing PVC with lead

New York State has recently introduced Bill A05147, which provides that on each seasonal and decorative lighting product manufactured, sold or delivered by a manufacturer or distributed in this state that contains an electrical cord casing made with polyvinyl chloride in which lead is used as a fire-retardant and stabilizer there shall be a warning label.

Click here to access Bill A05147.