UK exits the EU (ECHA advice to companies)

I posted earlier with the European Commission Notices to Companies. The European Chemicals Agency (ECHA) has also issued advice to companies. This covers :

(1) general

(2) Reach

(3) CLP (Classification, Labelling & Packaging)

(4) BPD – Biocides (see also my earlier post on the European Commission Notice to Companies, and Q&A)

(5) PIC

The ECHA information is accessed here

Endocrine Disruptors (EU)

On the 4th July 2017, EU Member States voted in favour of draft criteria to define endocrine disruptors in the area of plant protection products. These draft criteria are here. The criteria are based on the WHO definition of an endocrine disruptor, and apply to human health and also to the environment. 

The criteria will apply after a short transitional period of 6 months. 

EU legislation provides that active substances used in plant protection products are only approved for a limited period of time, and that these approvals are routinely reviewed. EU legislation for plant protection products also provides that active substances which are endocrine disruptors shall not be approved, unless there is negligible exposure in which case they may be approved under restricted conditions.

As regards the criteria for the environment, the specificity of some active substances which have endocrine modalities that affect target arthropods (e.g. insects) but do not affect vertebrates including humans has been acknowledged. These substances, of particular interest for integrated pest management, will be subjected to a specific risk assessment and only approved if there are no unacceptable effects on non-target organisms.

The question whether an active substance is an endocrine disruptor will be assessed each time the substance is subject to an approval or a renewal of approval at EU level.

The legal text setting out the criteria has been sent to the Council and the European Parliament. They will have three months (from July) to examine it before final adoption by the Commission. The text will enter into force 20 days after its publication in the Official Journal and be applicable six months after this (see above). 

In order to be ready to apply the criteria, EFSA and ECHA are preparing a joint Guidance document on endocrine disruptors. An outline was published on 20 December 2016 and a draft guidance document – already consulted with Member States and stakeholders – will be available for public consultation in autumn. After this public consultation, the guidance document will be finalised before the criteria start applying. It is important to recall that the criteria will apply also to the on-going procedures reassessing the substances. This post will be updated at that point. 

Further information is set out in this European Commission press release. Here

UK exits the EU (Notices to Business Operators)

I posted earlier re Medicines. The European Commission has now issued Notices to Business Operators in the following areas :

(1) GMOs – the Notice is here (this post will be updated when the Q&A is available). 

(2) Biocides – the Notice is here and the Q&A is here

(3) Pesticides and Plant Protection Products – the Notice is here and the Q&A is here.

Please pay close attention as the requirements differ with each legal instrument (topic). 

Plastic Microbeads in Cosmetics Ban (UK)

UPDATE 3rd August : the 2017 Regulations are now notified to the EU and to the WTO. The EU notification gives detail, and is here

A few days ago, the DEFRA Secretary of State confirmed the UK will introduce a ban on plastic microbeads in cosmetics and personal care products. Following consultation, the proposals are summarised :

(1) the ban on manufacture (England) will start 1st Jan 2018 and the ban on sale (England) will start 30th June 2018

(2) precise definitions of “microbead”, “plastic” and “rinse-off personal care product” have been developed to clearly define the scope of the ban

(3) the scope of rinse-off products will be as set out in the consultation, but DEFRA is additionally working with the Hazardous Substances Advisory Committee (HSAC) to assess the case for addressing further categories of products

(4) Trading Standards will be the regulator to manage compliance and enforcement in England

(5) enforcement in England will be carried out through a range of sanctions including variable monetary penalties, compliance notices, stop notices and enforcement undertakings

(6) the Devolved Administrations (Scotland, Wales and Northern Ireland) will consider appropriate enforcement mechanisms, regulators and timescales according to devolution settlements.

The summary of DEFRA responses is here.

Legislation is expected by the end of 2017. This is a UK initiative, and is unconnected with the EU. 

UK exits the EU (medicines and veterinary products)

On 2nd May 2017 the European Commission and the European Medicines Agency (currently based in London) issued a Q&A document. This first list of questions and answers addresses the establishment requirements (within the EEA), and will be updated.

The document is here. From 30th March 2019 00:00 hrs (CET) the UK will be a (EEA) third country, and the following provisions will apply :

(1) marketing authorisation holders must be established in the EEA (this includes Norway, Iceland and Liechtenstein),

(2) Qualified Persons for Pharmacovigilance (QPPV) must reside and carry out their tasks within the EEA,

(3) the Pharmacovigilance System Master File (PSMF) must be located within the EEA,

(4) active substances manufactured in the UK will be considered imported active substances, 

(5) medicinal products manufactured in the UK will be considered imported medicinal products, 

(6) batch release sites (for certification) must be located in the EEA. 

New European Carcinogens and Mutagens Directive (EU)

A further stage is reached yesterday in the creation of a new EU Directive to amend the existing Directive on this topic to introduce stricter limits on exposure values and skin notations for five carcinogens as well as skin notations independently of limit values for two more carcinogens, covering seven carcinogens in total.

The carcinogenic and mutagenic substances covered by the directive are the following: Mineral Oils that have been used before in internal combustion engines, certain polycyclic aromatic hydrocarbons (PAHs) mixtures, trichloroethylene, 4,4′-methylenedianiline, epichlorohydrine, ethylene dibromide, ethylene dichloride. 

The European Commission had submitted in January 2017 the proposed revision which concerns in particular annexes I and III of directive 2004/37/EC. 

The retained limit values are based on an analysis of economic, social and environmental impacts of the different policy options for each chemical agent, on the criteria of the scientific advice of the scientific committee on occupational exposure limits (SCOEL), effectiveness, efficiency and coherence. 

The limit values were also agreed by the advisory committee on health and safety at work (ACSH). 

This revision follows an earlier Commission proposal which already included 13 carcinogenic agents.

A further package of proposed limit values is expected to be adopted by the Commission at the beginning of next year. 

The current documents are found here

Microbeads New Legislation (UK)

The UK government is consulting, with the objective of new legislation by October 2017, to ban the sale and marketing of cosmetics and personal care products containing microbeads that may harm the marine environment.

Notification of the new legislation will be by email. 

The consultation supporting document (that sets out the detail) is here.