Eurofins | July 2019 regulatory Newsflash compilation | Chemicals

Europe

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
12/06/2019	Commission Implementing Decision (EU) 2019/961 of 7 June 2019 authorising a provisional measure taken by the French Republic in accordance with Article 129 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) to restrict the use and the placing on the market of certain wood treated with creosote and other creosote-related substances.	C/2019/4122
12/06/2019	Commission Regulation (EU) 2019/957 of 11 June 2019 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 (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) silanetriol and TDFAs. Restriction applicable to organic solvents in spray products (meaning aerosol dispensers, pump sprays, trigger sprays, marketed for proofing or impregnation spray applications).	C/2019/4176
17/06/2019	Recent substances published for restriction intention: Undecafluorohexanoic acid (PFHxA), its salts and related substances (EC -, CAS -) has been updated. The new submission date is now 20 December 2019 (previously 27 September).	Registry of restriction intentions until outcome here.
19/06/2019	Final opinion of the Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) to restrict substances in tattoo inks and permanent make up (EC -, CAS -) is now available.	Registry of restriction intentions until outcome here.
19/06/2019	Recent Public consultations launched: Restrictions of skin sensitising substances. PFHxS. SEAC's draft opinion on proposed restriction of polycyclic-aromatic hydrocarbons (PAHs).	Submitted restrictions under consideration here.

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
12/06/2019	Intentions to harmonise classification and labelling have been received for: Dibutyltin maleate (EC 201-077-5, CAS 78-04-6). Dibutyltin oxide (EC 212-449-1, CAS 818-08-6). Multi-walled carbon nanotubes (fibres fulfilling the WHO definition: diameter < 3 µm, fibre length > 5 μm and aspect ratio ≥ 3:1, with a diameter > xx nm) (EC -, CAS -).	Registry of CLH intentions until outcome here.
19/06/2019	Public consultation on harmonised classification and labelling for: 2-Ethylhexanoic acid and its salts, with the exception of those specified elsewhere in this Annex. N-(5-chloro-2-isopropylbenzyl)-N-cyclopropyl-3-(difluoromethyl)-5-fluoro-1-methyl-1H-pyrazole-4-carboxamide; isoflucypram. The deadline for comments is 26^th July 2019 Quinoclamine (ISO); 2-amino-3-chloro-1,4-naphthoquinone (EC 220-529-2, CAS 2797-51-5). Tellurium (EC 236-813-4, CAS 13494-80-9). Tellurium dioxide (EC 231-193-1, CAS 7446-07-3). The deadline for comments is 16^th August 2019.	Harmonised classification and labelling public consultations here.
19/06/2019	New intentions for a proposal to harmonise classification and labelling have been submitted for: Bis(4-methylbenzoyl)peroxide (EC 407-950-9, CAS 895-85-2) by Germany.	Registry of CLH intentions until outcome here.

Regulatory proposals notified to WTO

Below a summary table with some recent notifications to World Trade Organization (non-exhaustive):

Notification number / Link

Country

Title

G/TBT/N/CHE/235

Switzerland

Ordinance of the Federal Council amending the Ordinance on the Reduction of Risks relating to the Use of Certain Particularly Dangerous Substances, Preparations and Articles (Chemical Risk Reduction Ordinance, ORRChem) of 18 May 2005; 58 to 60 pages (depending on the language version); German, French, and Italian.

New restrictions on the marketing on certain hazardous substances shall be introduced in several annexes of the Chemical Risk Reduction Ordinance (ORRChem). The proposed provisions are:

Decabromodiphenyl ether (DecaBDE).
Perfluorooctanoic acid (PFOA) and its salts and precursors.
Certain phthalic acid esters (DEHP, DBP, DIBP, BBP) in articles.
Cyclotetrasiloxane (D4) and cyclopentasiloxane (D5) in cosmetics.
Nonylphenol ethoxylates (NPEOs) containing textiles.
Ammonium salts in cellulose insulation mixtures.
Methanol in windscreen fluids.
Fluorinated greenhouse gases.

EPA’s public comment for 5 chemicals under the Toxic Substances Control Act

On 21^st June 2019, the U.S. Enviromental Protection Agency published the following news: “EPA Meets Another Lautenberg Deadline: Proposes Persistent, Bioaccumulative, and Toxic Chemicals Rule under the Toxic Substances Control Act”.

Section 6(h) of TSCA (Toxic Substances Control Act) requires EPA to propose a rule “to address the risks of injuries to health or the environment that the Administrator determines are presented by the chemical substance and to reduce exposures to the substance to the extent practicable,” no later than June 22, 2019.

Following TSCA requirement, on 21^st June 2019, EPA proposed for public comment a rule to reduce exposures to certain chemicals that are persistent, bioaccumulative and toxic (PBT).

Therefore, EPA met the deadline and the 5 substances for public consultation are:

Decabromodiphenyl ether (DecaBDE).
Phenol, isopropylated phosphate (3:1) or PIP (3:1).
2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP).
Hexachlorobutadiene (HCBD).
Pentachlorothiophenol (PCTP).

Comments on the proposal will be accepted for 60 days from the notice’s formal publication in the Federal Register.

Click here for risk management details from EPA’s website.

Click here for more information from EPA’s website.

US | California

California Proposition 65 Reformulations (June, 2019)

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 some recent consent agreements are summarized as below:

Product

Chemical

Limit

Case No

Rain slickers and dog whistles.

Lead

DEHP

100 ppm

1000 ppm

Products exceed the limit shall utilize a warning statement.

Out of court

Revised guidelines for formaldehyde emissions in composite wood products

On 16^th May 2019, the California Air Resources Board (CARB) published two updated guidelines for composite wood products under the CARB and the US EPA Title VI Regulation.

The aim of these guidelines is to provide assistance to comply with the mentioned legislation.

The guidelines are:

For California the more stringent requirement shall be applied in case of differences between CARB and EPA requirements.

US | Minnesota

Minnesota Strengthens Flame-retardant Chemicals Law in Certain Products

On May 22, 2019, Minnesota’s governor signed flame retardant bill HF 359 into law which amends Minnesota Statutes 2018, section 325F.071 by expanding the scope of products and flame retardants.

From July 1, 2021, manufacturers or wholesalers are not allowed to manufacture, sell, offer for sale, distribute for sale, or distribute for use in this State a children's product, upholstered residential furniture, residential textile, or mattress that contain any organohalogenated flame retardant exceeding 1,000 parts per million in any product component. The effective date for retailer to observe this ban is July 1, 2022.

The following are exempt from this prohibition:

The sale or offer for sale of any previously owned product containing a chemical restricted under this section.
An electronic component of a children’s product, mattress, upholstered residential furniture, or residential textile or associated casing.
A children’s product, mattress, upholstered residential furniture, or residential textile where a federal flammability standard exists.
Thread or fiber used for stitching mattress components together.
Components of an adult mattress other than foam.

This new law also restricts the use of PFAS chemicals in firefighting foams.

For more information click here.

US | New Jersey

New Jersey prohibits Asbestos in all kind of products

As already announced in our Eurofins News Flash May 2019 edition, in March 2019, New Jersey passed Assembly Bill A4416 to prohibit the sale or distribution of products containing asbestos in this State.

On 10^th May 2019, the Bill AB 4416 was signed (“An Act Concerning the Sale or Distribution of Products Containing Asbestos, and Supplementing Title 13 of the Revised Statutes”).

The prohibition will become effective on 1^st September 2019.

US | New York

New enforcement date for Household Cleansing Product Disclosure Program

On 12^th June 2019, New York Department of Environmental Conservation (DEC) published a notice indicating that the enforcement date 1^st July 2019 is postponed to 1^st January 2020 for Household Cleansing Product Disclosure Program.

The aim of this program is to disclose ingredient information of household cleaning products in products’ website.

The Commissioner of NYS DEC has determined the form for disclosure and a phased implementation schedule.

International

The eighth revised edition of the GHS Purple Book

In May 2019, the 8^th Revision of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS, Rev.8) was published. The main points are:

Change of Classification Criteria for Aerosols.
New Hazard Category: Chemicals under Pressure.
Skin Corrosion/Irritation Classification Based on In Vitro/Ex Vivo Data.
New Precautionary Pictograms for “Keep out of Reach of Children”.
New Labeling Example for Sets or Kits.
Guidance on the identification of dust explosion hazards and the need for risk assessment, prevention, mitigation, and hazard communication.
Miscellaneous amendments to clarify the classification criteria for Specific Target Organ Toxicity.