Montreal Protocol – Kigali Amendment (International Law)

The Montreal Protocol on Substances that Deplete the Ozone Layer is a Protocol to the UNEP Vienna Convention for the Protection of the Ozone Layer. The Montreal Protocol is in force, sufficient states have ratified. In the EU bloc, the Montreal Protocol is given effect by an existing EU Regulation on Ozone Depleting Substances. In addition, a separate EU Regulation regulates Fluorinated Greenhouse Gases (F-gases).

The Kigali Amendment is specifically focussed on the global phasedown of hydrofluorocarbons (HFCs) – powerful greenhouse gases. HFCs account for 85% of present F-gas supply. UNEP has a FAQ here.

HFCs, used mainly in refrigeration, air conditioning and heat pump equipment, are thousands of times more harmful to the climate than CO2. In response to the rapid growth of HFC emissions, the 197 parties to the Montreal Protocol adopted the Kigali Amendment in 2016 to reduce gradually their global production and consumption.

The EU has been phasing down HFCs since 2015 (and has a separate EU Regulation on the matter). EU Member States are in the process of ratifying the Kigali Amendment individually.

All 197 Montreal Protocol parties agreed to take steps to gradually reduce the production and use of HFCs. The first reduction step to be taken by the EU and other developed countries is required in 2019, while most developing countries will start their phasedown in 2024.

The Kigali Amendment will enter into force on 1 January 2019.

Montreal Protocol parties continue to ratify the Amendment, which has so far been ratified by 60 parties. The parties, listed alphabetically, are: Austria, Australia, Barbados, Belgium, Benin, Bulgaria, Burkina Faso, Canada, Chile, Comoros, Costa Rica, Côte d’Ivoire, Czech Republic, Democratic People’s Republic of Korea, Ecuador, Estonia, European Union, Finland, France, Gabon, Germany, Greece, Grenada, Guinea Bissau, Hungary, Ireland, Kiribati, Lao People’s Democratic Republic, Latvia, Lithuania, Luxembourg, Malawi, Maldives, Mali, Marshall Islands, Mexico, Micronesia (Federated States of), Netherlands, Niger, Niue, Norway, Palau, Panama, Paraguay, Portugal, Rwanda, Samoa, Senegal, Slovakia, Sri Lanka, Sweden, Switzerland, Togo, Tonga, Trinidad and Tobago, Tuvalu, Uganda, United Kingdom of Great Britain and Northern Ireland, Uruguay, Vanuatu.

A useful assessment of the EU F-gas regulation dating March 2018 is here.

This highlights the further changes mandated by the Kigali Amendment to implement a HFC licensing system.

BREXIT : the UK has ratified the Kigali Amendment

US : the US has not yet ratified the Kigali Amendment

China : China has not yet ratified the Kigali Amendment

A useful assessment of the US and China current state is here. (Source – here)

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

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.