New Chemicals Instructions (EU Brexit Preparedness)

ECHA (the European Chemicals Agency) has new support pages – here.

These pages contain the most detailed information so far.

The UK has also issued Technical Notices, some of these are relevant for Chemicals. But, many gaps still persist.

Please visit the Chemicals category on this Blog, for the posts I have written on Chemicals and Brexit Preparedness.

We still have no instruction on Safety Data Sheets.

Chemicals Regulation (UK Brexit Preparedness)

Very little direct Brexit instruction is published by the UK on Chemicals Regulation, beyond the UK Technical Notices (I already posted about on this Blog). The EU also has its own Brexit Preparedness Notices (I already posted about on this Blog).

Today (7th November) the House of Lords EU European Union Committee published its report of evidence taken on the matter. This report is here,

There is agreement between the Government, industry and NGOs that the UK’s continued participation in REACH, the main system of EU chemical regulation, and continued membership of the European Chemicals Agency would be the best Brexit outcome.

But UK Brexit Preparedness is not advanced.

The Report identifies the following as requiring urgent attention (by Government) :

(1) clarifying its intended approach to chemical regulation in the future;

(2) creating and populating a database of chemicals;

(3) preparing a UK body to take on the role of chemical regulation in a way that is independent, transparent and scientifically robust;

(4) enabling businesses, including small businesses, to take pre-emptive action to maintain valid registrations for the EU market; and

(5) mitigating the economic impact on the chemical industry that would result from leaving the EU system.

NOTE THIS (referring to the evidence taken)

If associate membership of and ongoing participation in ECHA are not negotiated by exit day, a number of challenges arise. The first is the fact that, barring any preventative action, all chemical registrations will become invalid in the UK, and all registrations made solely by UK companies will become invalid in the EU. This would prevent the trade and use of those chemicals.

Peter Smith, Executive Director for Product Stewardship at Cefic, explained that there were 21,000 chemicals registered through REACH, 5,000 of which were registered by UK companies.

However, Ms Bulleid made the point that where one of those 5,000 substances is registered jointly by both a UK-based company and an EU-27-based company, “some people will be able to put it on the [EU] market, but the UK registrants will not”.

Ms Lloyd agreed, stating that chemicals registered by UK companies will not be invalid in the EU “unless the only registrants of that substance are UK companies”.

As a result, UK companies will lose access to the EU market, but the number of chemicals that would be prohibited is unclear.

THE REPORT CONTINUES WITH THE EVIDENCE GIVEN BY MINISTERS ON THEIR STEPS ON THE MATTER OF ILLEGAL REGISTRATIONS – these include :

(1) a new statutory instrument (Brexit Regulation) to continue the validity of UK registrations by UK registered companies for the UK market

(2) a DEFRA Secretary of State observation (based on the EU Brexit Preparedness Notices) that UK companies can mitigate by transferring their registration to an EU based affiliate or representative, but this is acknowledged as not possible in advance of exit day so there would be

a void of weeks or months before such companies are able to export substances to the EU.

Ms Edwards acknowledged this difficulty, stating that “there has been some discussion suggesting that you would need some sort of mechanism in place to enable those registrations to be transferred in advance”, but indicating that no such provision had yet been put in place

ON THE MATTER OF THE UK DATABASE

Ms Peake informed us: “Defra has asked for £5.8 million to set up an IT infrastructure to register chemicals in the UK in the case of having to set up an independent UK chemicals regulation system.”

Ms Edwards stated: “We are trying to build a system that will replicate, as far as it can, what the ECHA system does. Some of the fuller functionality that is not necessarily required on day one will come on board on a slightly slower timescale, but the critical thing for day one is to have that registration function in place.”

PLEASE CONTINUE TO FOLLOW THIS BLOG

Persistent Organic Pollutants (EU)

The EU Regulation on Persistent Organic Pollutants will be reissued (recast). Consultation responses are here. The proposal is here.

Detail

The European Commission is recasting the Persistent Organic Pollutants Regulation (EC) No 850/2004 (the current POPs regulation) which implements the commitments of the EU under the Stockholm Convention on POPs, and also takes account of the 1998 protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on POPs (protocol). Most EU countries, including the UK, are party to the Stockholm Convention and the protocol in their own right and as a member of the EU.

Persistent Organic Pollutants (POPs) are substances that remain intact in the environment for long periods, become widely distributed geographically, accumulate in the fatty tissue of humans and wildlife, and have harmful impacts on human health or on the environment. Examples of POPs include polychlorinated biphenyls (PCBs) and pesticides such as DDT.

The reasons for this recast are:

i. The EU Council Directive which provides the legal basis for the comitology committee for this regulation has been revoked and the committee ceased to exist on 1 June 2015.

ii. The regulation needs to take into account updated procedural changes introduced by the ‘Lisbon treaty’, in particular, which rules are subject to implementing acts and which conditions apply to the adoption of delegated acts.

The Commission proposes a recast of the Regulation with three objectives:

(1) to align the provisions for adoption of detailed implementing rules with changes introduced under the Lisbon Treaty—and, in particular, to stipulate which rules are subject to implementing acts and which to delegated acts; (see above)

(2) to involve the European Chemicals Agency (ECHA) in supporting the scientific, technical and reporting aspects of the Regulation—this includes providing advice on substances that are being considered by the Stockholm Convention for bans and restrictions and compiling, registering and disseminating information provided by Member States on the implementation of the agreement; and

(3) to simplify the reporting provisions.

Nonetheless there are changes, see the consultation responses.

BREXIT : It is possible that the recast Regulation will enter into force prior to the end of the post-Brexit implementation period on 31 December 2020. As a result, the Regulation could be directly applicable in the UK until the end of that period.

The UK relevant ministry (DEFRA) indicates possible concerns regarding the introduction of delegated acts and the ability for Member States to scrutinise and participate in decision making on the setting of thresholds and the nomination of POPs under the Stockholm Convention. It is not clear exactly, says the Minister, how the Commission will manage the approval of use of POPs in closed site systems nor how they will set waste thresholds for POPs in products. She believes that clarification over the ECHA’s role will be key. This includes whether there will be a requirement to use committees such as the Risk Assessment Committee and the Committee for Socio Economic Analysis to set maximum limits for POPs content within an article. The POPs element of the article above the maximum limit must be destroyed, usually at high temperature. The Government will therefore seek this clarification regarding the application of delegated acts during the negotiations.

The Minister welcomes the use of ECHA to assist in the implementation of the regulation as it brings the POPs regime into alignment with the REACH Regulation. This, she says, will help prevent conflicting decisions for the same substances and align timelines at the international and EU level. The UK is supportive of strengthening the role of the ECHA, and will be seeking further clarification regarding its role in relation to the POPs Review Committee (POPRC) and reporting to ensure there are no additional resource impacts.

The UK also supports streamlining reporting, digitalisation, and encouraging the use of the Information Platform for Chemical Monitoring (IPCheM). While there is no longer a requirement for triennial reports, a requirement is proposed to keep up to date data uploaded on the IPCHeM platform, allowing the ECHA to provide six-monthly reports to the Commission. The IPCHeM brings together chemical monitoring data under a new platform, established in 2015. It also brings the general EU reporting in line with the requirements under the Stockholm Convention, including requests for information for POPRC and the reporting for the convention under Article 13. The UK will seek clarification regarding the information and reporting requirements and standards which will be set by the ECHA going forward to align with the portal. Until the UK clarifies its relationship with the EU and the ECHA the precise impact of these changes once the UK has left the EU remains unclear.

Medicines (UK and EU Brexit Preparedness)

UPDATE : the UK is consulting on making the MHRA standalone in the event of No Deal. The consultation is here. The MHRA is the UK Medicines and Healthcare Regulatory Agency.

Companies are reminded to plan for the UK’s withdrawal from the EU on 29 March 2019 and are advised to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU. In particular, EMA encourages companies to refer to the updated questions and answers and practical guidance for industry published on 19 June 2018.

While the evaluation of the risk of supply and shortages of centrally authorised medicines is on-going, all marketing authorisation holders are reminded to inform the Agency of any change of plans which may affect medicine supply to patients in Europe.

In addition, applicants submitting new marketing authorisation applications to EMA are reminded to ensure that the arrangements they are proposing in their application remain valid after Brexit and likewise make the necessary changes by 29 March 2019.

Companies are also reminded that, if they foresee a product supply issue with a medicine, they have a legal obligation to inform EMA.

The text in italics is part of the European Medicines Agency (EMA) press release issued today that informs that companies are stepping up and that the focus is now on 39 centrally authorised Medicines down from 108. The Press Release is here.

Marketing authorisation holders for over half of the 108 medicines have either taken steps to transfer their marketing authorisation to an EU27 country, change their qualified person for pharmacovigilance (QPPV), relocate their pharmacovigilance system master file (PSMF), adapt their logistics, supply chains and contracts, or relocate some manufacturing sites. According to EU law, the marketing authorisation holder, the QPPV, the PSMF and certain manufacturing sites need to be based in the European Economic Area (EEA) in order for a company to be able to market a medicine in the EU.

More Technical Notices (UK Brexit Preparedness)

The UK has today issued further Brexit Preparedness Notices. The existing online location is updated – here.

Please note particularly :

(1) CE marking – in the “Labelling products and making them safe” group

(2) Driving

(3) BAT standards – in the “Protecting the environment” group

(4) F-gases and ODS – in the “Protecting the environment” group

(5) The three Notices in the “Travelling between the UK and the EU” group

(6) Oil and gas activities – in the “Regulating energy” group

(7) European Works Councils in the “Workplace rights” group (already issued)

Any questions, please email me.

Indicative Occupational Exposure Limits (EU)

Directive 2017/164/EU – indicative occupational exposure limit values of 31 January 2017 establishing a fourth list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC, and amending Commission Directives 91/322/EEC, 2000/39/EC and 2009/161/EU (Text with EEA relevance) – is in force.

The Cardinal Environment EHS Legislation Registers and Law Checklists have the third list of indicative occupational exposure limit values. The fourth list is being added shortly.

The fourth list is based on Council Directive 98/24/EC concerning the protection of the health and safety of workers from the risks related to chemical agents in the workplace. This was the case for previous indicative lists.

Indicative occupational exposure limit values (IOELV) are health-based, non-binding values, derived from the most recent scientific data available and taking into account the availability of reliable measurement techniques.

For any chemical agent for which an IOELV has been set at European Union level, Member States are required to establish a national occupational exposure limit value. They also are required to take into account the European Union limit value, determining the nature of the national limit value in accordance with national legislation and practice.

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 21 August 2018 at the latest.

Regarding the limit values for nitrogen monoxide, nitrogen dioxide and carbon monoxide, Member States will be able to benefit from a transitional period ending at the latest on 21 August 2023.

The 2017 Directive establishes limit values for the following chemical agents:

Manganese and inorganic manganese compounds (as manganese)

Glycerol trinitrate

Carbon tetrachloride; Tetrachloromethane

Amitrole

Acetic acid

Hydrogen cyanide (as cyanide)

Methylene chloride; Dichloromethane

Vinylidene chloride; 1,1-Dichloroethylene

Tetraethyl orthosilicate

Acrylic acid; Prop-2-enoic acid

Nitroethane

Bisphenol A; 4,4′-Isopropylidenediphenol

Diphenyl ether

2-ethylhexan-1-ol

1,4-Dichlorobenzene; p-Dichlorobenzene

Acrolein; Acrylaldehyde; Prop-2-enal

Methyl formate

But-2-yne-1,4-diol

Tetrachloroethylene

Ethyl acetate

Sodium cyanide (as cyanide)

Potassium cyanide (as cyanide)

Diacetyl; Butanedione

Carbon monoxide

Calcium dihydroxide

Calcium oxide

Sulphur dioxide

Lithium hydride

Nitrogen monoxide

Nitrogen dioxide

Terphenyl, hydrogenated

Skin absorption feature of ten substances is noted.

Of the 33 substances above, 4 were already listed in the Annex to Commission Directive 91/322/EEC, one was listed in the Annex to Commission Directive 2000/39/EC and one in the Annex to Commission Directive 2009/161/EU. The establishment of new indicative limit values was recommended by SCOEL for the above six substances listed in the Annex to this Directive. They will be deleted from the Annexes to the previous directives on 21 August 2018.

The further lists on indicative occupational exposure limit values (in Cardinal Environment EHS Legislation Registers and Law Checklists):

• Commission Directive 91/322/EEC establishing indicative limit values

• Commission Directive 2000/39/EC establishing a first list of indicative occupational exposure limit values

• Commission Directive 2006/15/EC establishing a second list of indicative occupational exposure limit values

• Commission Directive 2009/161/EU establishing a third list of indicative occupational exposure limit values

UK – the EH40 list is reissuedhere (and will be added shortly to Registers and Law Checklists)

Ditto the Ireland list is updated, and Continental European Registers and Law Checklists will have their current lists updated.

UK exits the EU (UK-EU Future Relationship White Paper)

UPDATE : Barnier statement following the July 2018 General Affairs Council (Article 50) – here – note his reference to agrifoods (the UK proposal for EU alignment only relates to goods checked at the border, this leaves aspects such as GMOs and pesticides to diverge, as I pointed out below)

Following the Chequers Statement, that has been widely published in UK media, the UK Secretary of State for Exiting the European Union (DExEU) has today (12th July) issued the long awaited UK White Paper setting out the UK proposals for the UK-EU Trade Deal (the Future Relationship).

The Chequers Statement is here.

The UK issued White Paper is here.

Please read these in the context of the EU issued Brexit Preparedness Notices (I have posted about these before) here.

A few points to note in the UK issued White Paper :

(1) Paragraph 30 – the UK seeks participation in the ECHA, EMA and EASA. Re the ECHA, the UK seeks to ensure UK businesses could continue to register substances directly with the ECHA, rather than working through an EU-based representative.

(2) Paragraph 36 – the UK will tailor its food policy (including food labelling) locally.

UK-EU negotiations will re-commence with the EU on Monday.

The UK will bring forward it’s separate White Paper on the EU (Withdrawal and Implementation) Bill shortly. This Bill will give effect to the UK-EU Withdrawal Treaty. Prior to publication by the UK of this Future Relationship White Paper, EU had confirmed 80% of the UK-EU Withdrawal Treaty had been agreed.

The UK Trade Bill and Taxation (Cross-border Trade) Bills return for their Third Reading next week.