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.

Carcinogens & Mutagens (EU Law)

An amendment to European Directive 2004/37/EC (Carcinogens and Mutagens) is expected to be adopted in February 2017. This amendment will set exposure limits for a further 11 carcinogens in addition to those covered by the existing 2004 directive. These are: 

* respirable crystalline silica dust

* 1,2-Epoxypropane

* 1,3-Butadiene

* 2-Nitropropane

* acrylamide

* certain chromium (VI) compounds

* ethylene oxide

* o-toluidine

* refractory ceramic fibres

* Bromoethylene

* Hydrazine

The amendment will also revise the limits for vinyl chloride monomer and hardwood dusts in the light of more recent scientific data. 

There will be minimum requirements for eliminating and reducing all carcinogens and mutagens. In line with the existing 2004 Directive, Employers will have to identify and assess risks to workers who are associated with exposure to specific carcinogens (and mutagens), and prevent exposure where risks exist. 

Substitution by a non or less-hazardous process or chemical agent will be required where this is technically possible. 

Email Alerts will be sent out. The Amendment proposal is here

Glyphosate (UK) Regulatory Query

UPDATE (June 2016) : The European Commission has adopted an eighteen month extension of its current approval. 

Press Release is here.

The legal position (set out below) in the UK is unchanged. Please note : some Local Authorities may trial alternatives for use in parks and gardens (eg Bristol).

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Glyophosate is regulated in the UK as a pesticide. Under European Union (EU) rules, pesticides are only approved for use if a scientific assessment has identified no unacceptable risks to people or the environment. The EU current approval of glyphosate expires on 31st December 2015.

The matter of health risks being created by use of glyphosate was raised in a recent assessment by the World Health Organisation’s latest review of cancer risks of this chemical (a main ingredient of the popular herbicide Roundup).

UK Department of Environment, Food and Rural Affairs (DEFRA) responded on 29th April 2015 as follows to a Freedom of Request:

“As part of the review of glyphosate, the regulatory authority responsible for pesticides in Germany (BfR) has assessed the relevant data to see if EU approval can continue from 2016. BfR’s assessment has been circulated to the European Food Safety Authority (EFSA) and to all EU Member States for critical review. EFSA published the assessment on its website in March 2014 for a two month public consultation and has co-ordinated a peer review, conducted in February 2015. This involved all Member States’ pesticides regulatory authorities, European Food Safety Authority, EFSA, and it’s expert advisors.

EFSA is in the process of drawing up its findings in a formal conclusion, which will be sent to the Commission for consideration. In light of this conclusion, a decision will be taken either to renew the approval of glyphosate or not. If approval is renewed, products which contain the active substance will be separately re-assessed at Member State level, to confirm that they too continue to meet the required standards of safety.

If approval is not renewed, glyphosate products will be withdrawn from the market.

In the work carried out so far under the EU review, glyphosate has been judged not to show an ability to cause cancer in humans. In addition, predicted exposures from authorised uses of glyphosate were found to be within acceptable limits for all aspects of human health.”

The full text is here.

Liz Truss continues as UK DEFRA Secretary

Welcoming the continuation of Rt Hon Liz Truss MP as Secretary of State for UK Environment, Food and Rural Affairs (DEFRA).

DEFRA is a large UK government department responsible for policy and regulations on environmental, food and rural issues, covering:

* the natural environment, biodiversity, plants and animals 

* sustainable development and the green economy 

* food, farming and fisheries 

* animal health and welfare 

* environmental protection and pollution control 

* rural communities and issues 

DEFRA only works directly in England, by concordat works closely with the devolved administrations in Wales, Scotland and Northern Ireland, and generally leads on negotiations in the EU and internationally.

DEFRA’s work and priorities are delivered by 35 separate agencies and public bodies, listed here.