Eurofins | Newsflash - March 2018 | Chemicals

Europe

Amendment for Export and Import of Hazardous Chemicals

On 6 February 2018, the European Commission published Commission Delegated Regulation (EU) 2018/172 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

Click here for getting the Official Journal of the European Union.

Europe

New Initiatives and Drafts for RoHS

On 20 February 2018, the European Commission notified WTO (World Trade Organization) several Draft Commission Delegated Directives concerning exemptions from RoHS 2 (Directive 2011/65/EU) substance restrictions.

Below you can find summary table of the above mentioned drafts:

Reference	Title	Initiative
G/TBT/N/EU/543	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 lead in dielectric ceramic in certain capacitors	RoHS exemption (7c-II) for lead in dielectric ceramic in certain capacitors
G/TBT/N/EU/544	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 lead in PZT based dielectric ceramic materials for certain capacitors	RoHS exemption (7c-IV) for lead in PZT based dielectric ceramic materials for certain capacitors
G/TBT/N/EU/545	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 cadmium and its compounds in electrical contacts	RoHS exemption (8b) for cadmium and its compounds in electrical contacts
G/TBT/N/EU/546	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 lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages	RoHS exemption (15) for lead in solders to complete a viable electrical connection between semiconductor die and carrier
G/TBT/N/EU/547	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 lead and cadmium in printing inks for the application of enamels on glasses	RoHS exemption (21) for lead and cadmium in printing inks for the application of enamels on glasses
G/TBT/N/EU/548	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 lead bound in crystal glass as defined in Directive 69/493/EEC	RoHS exemption (29) for lead bound in crystal glass as defined in Directive 69/493/EEC
G/TBT/N/EU/549	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 lead oxide in seal frit used for making window assemblies for certain laser tubes	RoHS exemption (32) for lead oxide in seal frit used for making window assemblies for certain laser tubes
G/TBT/N/EU/550	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 lead in the plating layer of certain diodes	RoHS exemption (37) for lead in the plating layer of certain diodes

Europe - REACH

ECHA’s Enforcement Forum’s Latest Project (REF-4)

On 8 February 2018, the European Chemicals Agency (ECHA) published the REF-4 project report.

As mentioned in this report: “The aims of the project were to raise awareness of restrictions in REACH Annex XVII, to identify non-compliance related to restrictions in the EU-market, to follow-up with enforcement action and to achieve a greater degree of compliance and thus a greater degree of health and environmental protection”

The scope of the project included 14 different restriction entries in REACH Annex XVII as included in Table 1 of the project report as extracted below:

REACH Annex XVII Entry No.	Substances	Products tested
5	Benzene	Glues for consumers and professionals
6	Asbestos fibres	In articles
23	Cadmium and its compounds	Plastic materials/packaging and other articles, brazing fillers and jewellery
27	Nickel and its compounds	Jewellery and metal parts (e.g. buttons, zippers)
32	Chloroform	Glues for consumers and professionals
43	Azocolourants and Azodyes	Textile and leather articles
45	Diphenylether, octabromo derivative (OctaBDE)	Substances and mixtures and articles
47	Chromium VI	Leather articles and cement
48	Toluene	Adhesives and spray paints intended for the supply to the general public
49	Trichlorobenzene	Substances and mixtures
50	Polycyclic Aromatic Hydrocarbons (PAHs)	Articles for supply to the general public
51, 52	Phthalates	Toys and childcare articles
63	Lead and its compounds	Jewellery

Within other non-compliances, the highest non-compliance rates in the scope of the project were with: phthalates in toys, Cadmium in brazing fillers and Asbestos

As a summary, the results from this enforcement project show that there are significant amounts of non-compliant products (products containing restricted substances) on the EU/EEA market.

An extract from the ECHA’s project report: “As the non-compliance relating to REACH restrictions is not something that can be seen by just looking at the product, the only way to get into more compliance is to influence and enhance the responsibility of companies in the supply chain. They need to get information on the chemical composition of products they buy from their suppliers, and they need to have such agreements in force in the supply chain, that it is not worth selling non-compliant products further in the supply chain. In addition, the enforcement authorities need to continue enforcing the REACH restrictions by analysing products on the market”

Click here for getting the ECHA’s REF-4 project report.

Europe - REACH

New Draft Amendment for Annex XVII of Regulation (EC) No 1907/2006

On February 1^st 2018, the European Commission notified World Trade Organization (WTO) draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 (REACH) as regards certain substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B.

This draft would introduce a new entry into Annex XVII to REACH. It would prohibit the placing on the market of the substances listed in Appendix 12 (above specified concentrations) in:

Clothing or related accessories
Textiles other than clothing which, under normal or reasonably foreseeable conditions of use, come into contact with human skin to an extent similar to clothing
Footwear

Click here for getting the draft text.

Europe - REACH

3-Benzylidene Camphor as a Substance of Very High Concern

On 29 January 2018, the European Commission published Draft Commission Implementing Decision concerning the identification of 1,7,7-trimethyl-3- (phenylmethylene) bicyclo [2.2.1] heptan-2-one (3-benzylidene camphor) as a substance of very high concern pursuant to Article 57 (f) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4 pages, in English) - Reference:G/TBT/N/EU/537

This draft Commission Decision aims to identify 3-benzylidene camphor as a substance of very high concern because of its endocrine disrupting properties, the environmental effects of which give rise to an equivalent level of concern in accordance with Article 57 (f) of Regulation (EC) No 1907/2006 (REACH).

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

5 February 2018

Seven substances proposed for authorisation :

5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-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)

1-Methyl-2-pyrrolidone (NMP)(EC 212-828-1)

2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)(EC 247-384-8)

2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)(EC 223-383-8)

2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)(EC 253-037-1)

2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)(EC 223-346-6)

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 (EC No. 201-559-5) (EC 271-094-0, 272-013-1)

Click here for getting the list of proposed substances for authorisation

Click here for getting the Eighth recommendation

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: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 February 2018	The harmonised classification and labelling proposal for the following substances is currently under public consultation until 13 April 2018: 2-(4-tert-butylbenzyl)propionaldehyde (lysmeral) (EC 201-289-8; CAS 80-54-6). dibenzo[def,p]chrysene; dibenzo[a,l]pyrene (EC 205-886-4; CAS 191-30-0). 2,4-dinitrophenol (EC 200-087-7; CAS 51-28-5). 4,5-dichloro-2-octyl-2H-isothiazol-3-one; [DCOIT] (EC 264-843-8; CAS 64359-81-5) phosphine (phosphane) (EC 232-260-8; CAS 7803-51-2). pirimiphos-methyl (ISO); O-[2-(diethylamino)-6-methylpyrimidin-4-yl] O,O-dimethyl phosphorothioate (EC 249-528-5; CAS 29232-93-7)	Click here for public consultation list
7 February 2018	Six new intentions to harmonise the classification and labelling have been received for: (5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone; pyriofenone (EC -, CAS 688046-61-9) mecoprop-P (ISO); (R)-2-(4-chloro-2-methylphenoxy)propionic acid (EC 240-539-0, CAS 16484-77-8) methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alaninate; valifenalate (EC -, CAS 283159-90-0) (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate (EC -, CAS 1101132-67-5) Thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine (EC 428-650-4, CAS 153719-23-4) bentazone (ISO); 3-isopropyl-(1H)-2,1,3-benzothiadiazin-4-(3H)-one 2,2-dioxide (EC 246-585-8, CAS 25057-89-0)	Click here to check the Registry of CLH intention until outcome

US- California

Three New Substances Listed Under Proposition 65

In December 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) published the following substances under the Safe Drinking Water Enforcement Act of 1986 (Proposition 65):

Chemical name	CAS number	Use	Date of listing	The warning regulations will become operative
Chlorpyrifos	2921-88-2	Organophosphate pesticide	15 December 2017	30 August 2018
n-Hexane	110-54-3	Widely used industrial solvent present in varnishes, cements, glues, and inks	15 December 2017	30 August 2018
Vinylidene chloride (1,1-Dichloroethylene)	75-35-4	Comonomer in the polymerization of vinyl chloride, acrylonitrile, acrylates and production of adhesives, fibers, refrigerants, food packaging and coating resins.	29 December 2017	30 August 2018

US- California

California Proposition 65 Reformulations (February, 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 to carcinogenic and toxic for reproduction chemicals by reformulating consumer products containing such chemicals.

In order to keep retailers and manufacturers up-to-date, highlights of some recent consent agreements are summarized as below:

Product	Chemical	Limit	Case No
Plastic weekly planner products	DEHP, DINP	1000ppm Products exceed the limit shall utilize a warning statement.	Out of court
Cleaning tool	Lead	300ppm Products exceed the limit shall utilize a warning statement.	Out of court

Canada

Canada proposes to amend the Products Containing Mercury Regulations

On February 1st, 2018, Environment and Climate Change Canada (ECCC) published a consultation document online proposing to amend the Products Containing Mercury Regulations (the Regulations).
The proposed amendments contains following main elements:

Alignment with the requirements under the Minamata Convention;
Amendments to further align with other international initiatives ;
Amendments to the non-applications;
Adjustments to certain elements of the labelling requirements;
Amendments to testing requirements to broaden the accreditation bodies recognized under the regulations;
Amendments to the reporting requirements;
Amendments to the record keeping requirements;
Adjustments to clarify certain exemptions in the schedule of the regulations.

Stakeholders can submit comments by April 2^nd, 2018. Click here for more details

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