EU: Substances Potentially Subject to Compliance Checks During 2017 under REACH, Revised List, August 2017

ECHA’s announcement of REACH compliance reviews seems to be about dossiers, rather than end products. The compliance check will mainly focus on eight key endpoints such as reproduction toxicity, carcinogenicity, biodegradation and bioaccumulation. There are still difficulties getting the SIEFs and registrants connected to final manufacturers and end products.

ECHA has started to implement its new compliance check strategy. The goal is to increase efficiency and transparency in dossier evaluation and focus on those substances that matter the most for human health and the environment. Some practices will also change as of January 2015.

Increased transparency of compliance check plans

ECHA starts publishing a list of substances for which a compliance check would in all probability be conducted. This gives the registrants the possibility for early dossier updates before the compliance check starts. However, the list is indicative and non-exhaustive: ECHA reserves the right to open further compliance checks on any dossier at any time and without prior notice to the registrants.

The compliance check will mainly focus on eight key endpoints which are outlined in the new compliance check strategy. These are genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation endpoints.

Compliance checks: no dossier updates considered during the decision-making

To shorten processing times, ECHA will no longer take into account dossier updates after the draft decision on a compliance check has been sent to the registrant for comments.

The change does not affect the 30-day period given to registrants to submit comments on the draft decision. Comments will be taken into account in the decision making.

ECHA continues to offer informal interaction with registrants to clarify the process and content of the draft decision. The registrants are expected to update their dossier after the final decision, before the given deadline. ECHA will evaluate whether the requirements of the decision are met after this deadline.

Testing proposals: 60 days to update

When the registrants receive a draft decision on a testing proposal, they will have 30 days to comment and a further 30 days to update their dossier, where relevant. To avoid unnecessary testing on vertebrate animals, a more flexible approach may on request be taken in case of testing proposals involving read-across and categories for two or more registered substances. The applicable deadlines will be stated in ECHA’s draft decision and the notification letter.

ECHA tightens its practice on dossier updates  authored by European Chemicals Agency (ECHA) on Jan 28, 2015

 

 

China: Implementing the Minamata Convention on Mercury, Announcement No. 38, 2017

China’s implementation of the 2013 Minamata ban on mercury mining, production, import, and export as of August 2017 follows the ratification of the UN binding convention, based on recent surpassing of needed 50 nations support. This obligation will remove one of the last places mercury will likely be used in product manufacture, as its phase-out in switches and displays for autos, and other uses in consumer products has been on-going for over a decade.

On 15 August 2017, China’s MEP with other Ministries jointly published the Announcement on Implementing the Minamata Convention on Mercury, to take effect on 16 August 2017.

From 16 August 2017 manufacturers, importers and exporters shall comply with the Minamata Convention and national requirements on importing and exporting hazardous chemicals. The Announcement imposes the following bans, effective from 16 August 2017:

Ban on raw mercury mining;

Ban on production of chlor-alkalie using mercury or mercury compounds;

Ban on production of switches and relays containing mercury;

Ban on production of mercury compounds (highly toxic pesticide products);

Ban on manufacture of mercury batteries;

The Ministry of Commerce will add the products containing mercury to the Catalogue of Products Prohibited from Import and Export. Per the Convention, phase out of the manufacture, import or export of mercury-added products listed in the Annex.

Products containing mercury are listed in the Annex, including:

Batteries

Switches and Relays

Lighting equipment – compact fluorescent lamps, straight tube fluorescent lamps, high pressure mercury lamps,

Cold cathode fluorescent lamps, and external electrode flourescent lamp

Cosmetics

Pesticides, bio-pesticides, and local antibacterial agent

Non-electronic measuring equipment

EU: Biocidal Products Regulation (EU) No 528/2012

The European Biocidal Products Regulation, while having been in place and updated in 2017 is showing product reporting impact as automotive companies expect suppliers using the new Chemistry Manager feature within IMDS to attempt to get material supplier regulatory information on potential biocidal substances.

The European Biocidal Products Regulation, while having been in place and updated in 2017 is showing product reporting impact as automotive companies expect suppliers using the new Chemistry Manager feature within IMDS to attempt to get material supplier regulatory information on potential biocidal substances.

This Regulation lays down rules for:
(a) the establishment at Union level of a list of active substances which may be used in biocidal products;
(b) the authorisation of biocidal products;
(c) the mutual recognition of authorisations within the Union;
(d) the making available on the market and the use of biocidal products within one or more Member States or the Union;
(e) the placing on the market of treated articles.