Eurofins | June 2019 regulatory Newsflash compilation | Chemicals

Europe

Proposal to add 12 SVHCs to REACH Annex XIV-Authorisation List

On 24^th April 2019, the European Commission opened a public consultation on the proposal to add 12 substances of very high concern (SVHCs) to Annex XIV- authorization list of the EU REACH legislation. EU Commission announces that the planned addition of 12 substances to the REACH Authorization List would be done by October 2019.

Below a summary table with the substances that would be added in Annex XIV to Regulation (EC) No 1907/2006:

Entry	Substance	CAS number	EC Number
44	1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear.	68515-50-4	271-093-5
45	Dihexyl phthalate.	84-75-3	201-559-5
46	1,2-benzenedicarboxylic acid, di-C6- 10-alkyl esters; 1,2- benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate.	68515-51-5; 68648-93-1	(201-559-5) 271-094-0; 272-013-1
47	Trixylyl phosphate.	25155-23-1	246-677-8
48	Sodium perborate; perboric acid, sodium salt.	-	239-172-9; 234-390-0
49	Sodium peroxometaborate.	7632-04-4	231-556-4
50	5-sec-butyl-2-(2,4-dimethylcyclohex3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof] (karanal group).	-	-
51	2-(2H-benzotriazol-2-yl)-4,6- ditertpentylphenol (UV-328).	25973-55-1	247-384-8
52	2,4-di-tert-butyl-6-(5- chlorobenzotriazol-2-yl)phenol (UV-327).	3864-99-1	223-383-8
53	2-(2H-benzotriazol-2-yl)-4-(tertbutyl)-6-(sec-butyl)phenol (UV-350).	36437-37-3	253-037-1
54	2-benzotriazol-2-yl-4,6-di-tertbutylphenol (UV-320).	3846-71-7	223-346-6
55	Diazene-1,2-dicarboxamide (C,C'- azodi(formamide)) (ADCA).	123-77-3	204-650-8

The public consultation was closed on 22^ndMay 2019.

For more information click here.

Eye hazard CLP classification evaluation for detergents and cleaning products

On 6^th May 2019, the International Association for Soaps, Detergents and maintenance Products (AISE) announced the publication of a scientific paper about the eye hazard classification and the effects in case of accidental exposure to detergents and similar products.

European detergent industry and Scientists and experts from several European Poison Centres collaborated together in the writing of this scientific paper which indicates that effects in accidental exposure are lower than the hazard classification that is indicated in the packaging of these products.

Click here for more information.

Recent publications by the European Commission

Below some recent publications by the European Commission (not exhaustive list):

Reference	Date	Title
PE 11 2019 INIT	08/05/2019	DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the reduction of the impact of certain plastic products on the environment. This draft describes circular approaches that give priority to sustainable and non-toxic re-usable products and re-use systems rather than to single-use products, aiming first and foremost to reduce the quantity of waste generated.
C/2019/2805	26/04/2019	COMMISSION IMPLEMENTING DECISION (EU) 2019/665 of 17 April 2019 amending Decision 2005/270/EC establishing the formats relating to the database system pursuant to European Parliament and Council Directive 94/62/EC on packaging and packaging waste.
C/2019/2942	24/04/2019	COMMISSION REGULATION (EU) 2019/636 of 23 April 2019 amending Annexes IV and V to Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants.
ST/7893/2019/INIT	24/04/2019	COUNCIL DECISION (EU) 2019/639 of 15 April 2019 on the position to be taken on behalf of the European Union at the ninth meeting of the Conference of the Parties as regards amendments to Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants.
02017D1215-20190315	15/03/2019	Consolidated version: Commission Decision (EU) 2017/1215 of 23 June 2017 establishing the EU Ecolabel criteria for industrial and institutional dishwasher detergents. (notified under document C(2017) 4228).
02017D1214-20190315	15/03/2019	Consolidated version: Commission Decision (EU) 2017/1214 of 23 June 2017 establishing the EU Ecolabel criteria for hand dishwashing detergents (notified under document C(2017) 4227).
02017D1218-20190315	15/03/2019	Consolidated version: Commission Decision (EU) 2017/1218 of 23 June 2017 establishing the EU Ecolabel criteria for laundry detergents (notified under document C(2017) 4243).

Regulatory proposal 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/EU/652	Europe	Draft Commission Delegated Directive 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 bis(2-ethylhexyl) phthalate (DEHP) in certain rubber components used in engine systems.

Draft texts notified to the European Commission

The following draft document has been recently notified to the European Commission:

Reference

Date

Country

Title

2019/192/A

29/04/2019

Austria

Federal Law amending the Waste Management Act 2002 [Abfallwirtschaftsgesetz] (AWG Legal Consolidation Amendment 2019).

This draft Law contains a general ban on plastic carrier. This marketing ban shall enter into force on 1 January 2020.

Standards Updates

Below a summary table with some recent standards updates and upcoming dates of withdrawal and/or availability (non-exhaustive):

(*) 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 Availability ()**	Supersedes
CEN ISO/TS 21083-2:2019	Test method to measure the efficiency of air filtration media against spherical nanomaterials - Part 2: Size range from 3 nm to 30 nm (ISO/TS 21083-2:2019).	2019-04-03	-

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
17/04/2019	Publication of annual report on integrated regulatory strategy: Mapping the chemical universe to address substances of concern.	Registered substances mapped for regulatory action here.
25/04/2019	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the marketing and use of explosives precursors, amending Annex XVII to Regulation (EC) No 1907/2006 and repealing Regulation (EU) No 98/2013 on the marketing and use of explosives precursors - Outcome of the European Parliament's first reading (Strasbourg, 15 to 18 April 2019).	ST 8414 2019 INIT
08/05/2019	Intention to restrict oxo-degradable plastics withdrawn. The new legislation restricts the placing on the EU market of any product made from oxo-degradable plastics two years after the directive enters into force.	Click here for more information from ECHA website.
15/05/2019	ECHA is working to develop a database With information on articles containing substances of very high concern (SVHCs). Early 2020 – Prototype of database ready for testing.	Click here for more information about database and waste directive.

Additional 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
06/05/2019	Public consultation on harmonised classification and labelling for: 2-(2-methoxyethoxy)ethanol (EC 203-906-6; CAS 111-77-3). Pyridine-2-thiol 1-oxide, sodium salt; pyrithione sodium; sodium pyrithione (EC 223-296-5, 240-062-8; CAS 3811-73-2 15922-78-8). Methyl methacrylate methyl 2-methylprop-2-enoate; methyl 2-methylpropenoate (EC 201-297-1, CAS 80-62-6). The deadline for comments is 5^th June 2019. 2-(2-methoxyethoxy)ethanol (EC 203-906-6; CAS 111-77-3). Pyridine-2-thiol 1-oxide, sodium salt; pyrithione sodium; sodium pyrithione (EC 223-296-5, 240-062-8; CAS 3811-73-2 15922-78-8). It is an active substance mainly used in biocidal products as a preservative and disinfectant. Methyl methacrylate methyl 2-methylprop-2-enoate; methyl 2-methylpropenoate (EC 201-297-1, CAS 80-62-6). The deadline for comments is 5^th July 2019.	Harmonised classification and labelling public consultations here.
06/05/2019	New intentions for a proposal to harmonise classification and labelling have been submitted for: 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (EC 216-036-7, CAS 1478-61-1) by Sweden. Hydrogen sulphide (EC 231-977-3, CAS 1478-61-1) and benzyl alcohol (EC 202-859-9, CAS 100-51-6) by Germany. 1-phenylethan-1-one (1-phenylethylidene)hydrazone (EC 211-979-0, CAS 729-43-1) by France.	Registry of CLH intentions until outcome here.
06/05/2019	New Proposals to harmonise classification and labelling have been submitted for: Barium diboron tetraoxide (EC 237-222-4, CAS 13701-59-2) by Sweden. Cumene (EC 202-704-5, CAS 98-82-8) by Denmark. Benfluralin (EC 217-465-2, CAS 1861-40-1) by Norway. Oxamyl (ISO); N',N'-dimethylcarbamoyl(methylthio)methylenamine N-methylcarbamate (EC 245-445-3, CAS 23135-22-0) has been submitted. By Italy.	Registry of CLH intentions until outcome here.
06/05/2019	News proposal to harmonise the classification and labelling has been withdrawn for: 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) by Slovenia.	Registry of CLH intentions until outcome here.

France

Titanium dioxide in nanoparticulate form

In April 2019, ANSES (Agence Nationale de Sécurité Sanitaire Alimentation, Environnement, Travail) published a Reference Toxicological Value (TRV) for chronic inhalation exposure for Titanium dioxide in nanoparticulate form.

Nanoparticulate Titanium dioxide is used in many industrial and commercial applications. As part of its national mission to develop reference health values, ANSES was asked to define a TRV for Titanium dioxide in nanoparticulate form (TiO2 -NP).

Following a thorough analysis of all available toxicity data, the Agency recommends a chronic inhalation TRV for the P25 form of TiO2-NP of 0.12 μg.m-3.

Based on this reference value, health risk assessments will be carried out as part of plant and industrial site management actions in France. This is also the first VTR developed for a nanomaterial in France.

Click here for going the ANSES’ publication (in French).

Guidance for substances in contact with infant formula

On 9^th May 2019, the U.S. Food and Drug Administration (FDA) published the guidance for Industry about Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk in Federal Register.

This document is intended to help manufacturers or suppliers in the preparation of food contact notification (safety assessment) for substances that can be in infant formula packaging for both liquid and powdered formula, baby bottles, bottle inserts, nipples, and any others materials.

Click here for getting the FDA’s Guidance.

Regulatory proposal notified to WTO

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

Notification number / Link

Date

Title

G/TBT/N/USA/1476

29/04/2019

Proposed Modification to the List of Appropriate NRTL Program Test Standards and the Scopes of Recognition of Several NRTLs.

In this notice, the Occupation Safety and Health Administration proposes to:

Add new test standards to the Nationally Recognized Testing Laboratories (NRTL) Program's list of appropriate test standards.
Delete or replace several test standards from the NRTL Program's list of appropriate test standards.
Update the scope of recognition of several NRTLs.

Canada

A qualitative hazard-based approach to identify substances of low concern for human health

In March 2019, Health Canada published a science approach document for substances with low human health hazard potential.

The aim is to assist the government in addressing substances that are likely of low concern in an efficient and effective manner. Health Canada has evaluated a subset of 14 substances of the approximately 1550 remaining priority substances under the Chemicals Management Plan.

Click here for getting the science approach document.

Australia

New Australian Industrial Chemicals Introduction Scheme (AICIS) approaching

There is now a new Australian industrial chemicals law — the Industrial Chemicals Act 2019. This law creates a new regulatory scheme for the importation and manufacture of industrial chemicals in Australia (to replace NICNAS) from 1 July 2020.

The Australian Government – Department of Health has made available information about this new scheme in its website.

Department of Health’s website information about the following points can be found:

On the other hand, the Department of Health is currently assessing the human health and environmental risks of pentabromodiphenyl ether (pentaBDE) and published a call to compile information about this substance. Importers and manufacturers had time to provide information until 7^th June.

Click here for more information.

China

Arrangement for the implementation of Conformity Assessment System on the Restriction of the Use of Hazardous Substances in Electrical and Electronic products

On May 16^th 2019, the Departments of State Administration for Market Regulation (SAMR) and Ministry of Industry and Information Technology of the People’s Republic of China (MIIT) have recently enacted and issued “the Arrangement for the implementation of Conformity Assessment System on the Restriction of the Use of Hazardous Substances in Electrical and Electronic products” (the Implementation Arrangement) which will take effect from November 1^st, 2019.

Read more >>

South Korea

Risk Assessment for Food Contact Materials, Cosmetics and others

On 17^th April 2019, South Korea’s Ministry of Food and Drug Safety published the notification "Regulations on Risk Assessment Methods and Procedures, etc." to evaluate risk by taking into consideration the effects of harmful substances that can be ingested, inhaled and absorbed through various products such as food, medicine, and cosmetics, and to prepare risk assessment methods and procedures for medicines and medical devices. The aim is to complete comprehensive risk assessments by 2022 for 60 hazardous substances that come into contact with the body. The assessments are set to begin on July 1, 2019.

Click here for getting the official publication (in Korean).