More Technical Notices (UK Brexit Preparedness)

Further Technical Notices are published today. The collection is found here.

I will be shortly adding the Brexit Law list to Cardinal Environment EHS Legislation Registers and Checklists. Please look out for the links appearing in both ENV and OHS. This Brexit Law list will be added to over the coming months.

The UK Technical Notices identify a large number of new systems, new consultations, and new processes that will be brought on stream. Please continue to follow this Blog closely.

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i. The EU Council Directive which provides the legal basis for the comitology committee for this regulation has been revoked and the committee ceased to exist on 1 June 2015.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 (24th September 2018) published more Technical Notices, some have a slightly earlier date. The collection to date is here.

Please note in particular the new Notices issued in the topics of Importing and Exporting, and Product Labelling.

Please note there is now a Technical Notice on REACH. This only covers the registration side. Given its tone, I would envisage in the first instance Safety Data Sheets and Marketing and Use Restrictions might not alter much, if at all. I will Blog post again if there is further information issued or made available on this.

(1) The Health and Safety Executive (HSE) would act as the lead UK regulatory authority, from the day the UK leaves the EU, building on its existing capacity and capability.

(2) The new regulatory framework would: enable the registration of new chemicals through a UK IT system that is similar to the existing EU IT system; provide specialist capacity to evaluate the impact of chemicals on health and the environment; ensure sufficient regulatory and enforcement capacity in the HSE, the Environment Agency (EA) and other regulators, enabling them to recommend controls in response to the hazards and risks of substances; and provide for an appropriate policy function in Department for Environment, Food & Rural Affairs (Defra) and the devolved administrations.

(3) In a ‘no deal’ scenario the UK would not be legally committed to medium- or long-term regulatory alignment with the EEA.

Please note there is now a Technical Notice on the CTA between the UK and Ireland.

(1) If you are an Irish citizen you would continue to have the right to enter and remain in the UK, as now. You are not required to do anything to protect your status.

(2) In addition, you would continue to enjoy the reciprocal rights associated with the CTA in the same way that British citizens in Ireland would if there is no deal. These rights include the right to work, study and vote, access to social welfare benefits and health services. Where required domestic legislation and agreements would be updated to ensure that the CTA rights continue to have a clear legal basis.

(3) There would be no practical changes to the UK’s approach to immigration on journeys within the CTA: as now there would be no routine immigration controls on journeys from within the CTA to the UK. The legislation governing this approach will remain unchanged when the UK leaves the EU. So too will the legislative framework of integrated immigration laws between the UK and the Crown Dependencies. The CTA arrangements would be maintained, promoting the benefits of migration between these islands.

Please note the consultations proposed re GMOs.

Please email me if you need to discuss any matter.

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.

Life Science Sector (UK Brexit Preparedness)

UPDATE : further information on the Clinical Trials Regulation (issued 6th August) is here.

Today (6th August) the Department of Health & Social Care, the Medicines & Healthcare products Regulatory Agency and the Veterinary Medicines Directorate, together, issued Guidance.

The guidance is “What the implementation period means for the life science sector’. This document is here. NB – the implementation period is the UK term for the EU transition period.

The guidance states (and note, this is subject to EU-UK agreement of the Withdrawal Agreement) :

During the implementation period:

• pharmaceutical firms will be able to continue UK batch release testing and Qualified Person certification in the UK, with this being recognised by the EU and vice versa

• marketing authorisation holders and qualified persons for pharmacovigilance will continue to be able to be based in the UK and access EU markets. There will be continued mutual recognition of manufacturing and distribution licences, as well as associated inspections such as good manufacturing practice (GMP)

• firms based in the UK will be able to continue to apply for marketing authorisations via either the centralised or decentralised procedures

• for medical devices, CE marking will continue to be used and recognised for both the UK and EU markets, and UK-based industry will not require an authorised representative established in the EU. UK notified bodies will continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognised for both the UK and EU markets.

The document also states the UK reached agreement with the EU at March European Council that the UK is to be treated as a Member State for the purposes of international agreements, including Mutual Recognition Agreements, for the duration of the implementation period. The EU will notify other parties of this approach.

This means that there will be no disruption to existing relationships underpinned by international agreements as we move into the implementation period.

A vital issue is EU legislation enacted during this implementation/transition period, or enacted beforehand with forward enforcement dates in the period, or enacted after the period – below is illustrative (from this document, and applicable to this subject)

(1) The new Clinical Trials Regulation (CTR) is expected to be implemented during 2020 and would therefore apply to the UK under the terms of the time-limited implementation period.

If the new regulation does not come into force during the implementation period, the government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, so that researchers conducting clinical trials can plan with greater certainty.

Regardless of the outcome of the negotiations, the UK is committed to offering a competitive service for clinical trial assessment. This covers regulatory approval from MHRA as well as services from HRA, ethics services, NIHR and the NHS. (This is not applicable to the veterinary sector.)

(2) The EU Medical Devices Regulation will fully apply from May 2020. As this falls during the implementation period the government will fully implement the legislation.

(3) The new EU Regulation on in vitro diagnostic (IVD) medical devices will not apply until May 2022, which is outside of the implementation period. However, elements of both new devices regulations have applied directly in UK law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements. (This is not applicable to the veterinary sector.)

UK exits the EU (DEFRA preparations)

Ministerial approval is given [prior to the EU (Withdrawal) Bill Royal Assent] to the following projects – to ensure preparation for all negotiation outcomes :

(1) Delivery of a new national import control system for animals, animal products and high risk food and feed. Scheduled to commence building: mid-January 2018. Estimated cost before Royal Assent: £7m.

(2) Delivery of new IT capability to enable registration and regulation of chemical substances placed on the UK market. Scheduled to commence building: February 2018. Estimated cost before Royal Assent: £5.8m.

(3) Delivery of systems for the licensing and marketing of veterinary medicines. Scheduled to commence building: end-January 2018. Estimated cost before Royal Assent: £1.6m.

(4) Development of a new catch certificate system for UK fish and fish products being exported to the EU on Exit. Scheduled to commence: building end-January 2018. Estimated cost before Royal Assent: £1.0m.

(5) Development of a UK system to manage the quota of fluorinated gases and ozone depleting substances required under the UN Montreal Protocol. Scheduled to commence: March 2018. Estimated cost before Royal Assent: £0.5m.

(6) Development of data exchange arrangements to identify the movement of EU and third country vessels in UK waters and the movement of UK vessels in EU or third country waters. Scheduled to commence: April 2018. Estimated cost before Royal Assent: £0.1m

Note : regarding start dates – the Permanent Secretary letter is dated 18 January 2018 – here.

The Civil Service World article dated the next day confirms approval was given on the 18 January 2018 for these projects. The CSW article is here.