Substances of Very High Concern (UK REACH) (Britain)

The government (UKG) has today published its policy on how new chemicals will be added or existing chemicals removed from the Substances of Very High Concern candidate list (SVHC) that was fossilised as at the EU list on 31st Dec 2020. The policy paper is here.

When UK REACH came into force, all substances that were on the EU REACH candidate list were carried over onto the UK REACH candidate list. UK REACH applies in Britain, not Northern Ireland which follows EU REACH.

The UK REACH work programme for 2021-22 committed to assess those substances that have been added to the EU REACH candidate list since UK REACH came into force, to consider if it was appropriate to add them to the UK REACH candidate list.

To aid this assessment, DEFRA (UKG) and the Welsh and Scottish Governments agreed interim principles for including SVHCs on the candidate list in UK REACH:

1 Including SVHCs on the candidate list should be used to encourage substitution away from particularly hazardous substances.

2 A substance should not be proposed for inclusion on the candidate list unless it is a good candidate for the authorisation list.

3 Regulatory Management Options Analysis (RMOA), informed by calls for evidence, should be used to determine if inclusion on the candidate list is the correct route.

The Health and Safety Executive (HSE), with the Environment Agency (EA), used these interim principles to assess the substances that have been added to the EU REACH candidate list since UK REACH came into force. HSE and EA identified four substance groups as priorities for further assessment via Regulatory Management Options Analysis (RMOA):

• dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivatives, and any other stannane, dioctyl-, bis(fatty acyloxy) derivatives wherein C12 is the predominant carbon number of the fatty acyloxy moiety

• 1,4-dioxane

• small brominated alkylated alcohols (SBAA)

• phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerisation, covering any individual isomers and/or combinations thereof (PDDP)

These RMOAs will recommend the most appropriate route for managing any identified risks from these substances. This may include these substances being added to the candidate list, but HSE and EA may make other recommendations.

The Defra Secretary of State, Welsh ministers, Scottish ministers and HSE can put a substance forward for inclusion on the candidate list. They can do so if they consider it fulfils one or more of the technical, hazard-based criteria to be considered an SVHC. HSE will then prepare a dossier on, and consult on, the proposed addition to the candidate list. The final decision on whether to add a substance to the candidate list is made by HSE (with the EA advising on environmental matters).

Environment Act 2021 – summary (UK)

The Act is not yet published, neither is any commencement order, nor any regulation.

The closest text is the text as introduced to the House of Lords – here. Note, Environment is a devolved matter, which means the bulk of the Environment Act 2021 provisions relate to England only.

Key points –

(1) the government must set long-term targets in priority areas for England (and may set other long-term targets) – by regulations – air quality, water, biodiversity, resource efficiency and waste reduction. The government must then review these targets in the context of the significant improvement test in section 6.

(2) the government must publish a statement of environmental principles, to be used in policy making.

(3) the government must publish a report (at specified intervals) on developments in international environmental law.

(4) an Office for Environmental Protection (OEP) must be established in England, to carry out certain scrutiny and advice functions. Schedule 3 deals with the OEP as respects Northern Ireland.

(5) Schedule 4 confers powers to make regulations on producer responsibility, replacing authority in earlier legislation which is revoked. Schedule 5 confers powers to charge for disposal costs.

(6) Schedule 8 confers powers to make regulations to create deposit schemes.

(7) Schedule 9 confers powers to make regulations about charges for single-use plastic items.

(8) the Environmental Protection Act 1990 is amended with provisions about the separate collection of recyclable waste in England – glass, metal, plastic, paper and card, food waste.

(9) the Environmental Protection Act 1990 is amended with updated provisions for hazardous waste in England and Wales.

(10) the Waste and Contaminated Land (Northern Ireland) Order 1997 is amended with updated provisions for hazardous waste.

(11) the Environmental Protection Act 1990 is amended with updated provisions for transfrontier waste shipment.

(12) the government may make regulations to recall vehicles or engines on environmental grounds (section 73).

(13) the Water Resources Act 1991 (applicable England and Wales) is amended to require sewerage undertakers to publish and maintain a drainage and sewerage management plan. These provisions were strengthened slightly following consideration in the House of Lords (final Act text not yet published).

(14) the government (and the relevant authorities in the devolved administrations) may make regulations to change water quality standards.

(15) Schedule 14 provides for biodiversity gain to be a planning condition.

(16) the Natural Environment and Rural Communities Act 2006 section 40 duty to conserve biodiversity (England) is substantively enhanced.

(17) local authorities in England must publish biodiversity reports at specified intervals.

(18) there must be more local nature recovery strategies so that they cover the whole of England.

(19) Natural England is empowered to publish a strategy for improving the conservation status of any species of flora or fauna (a special conservation strategy).

(20) Natural England is empowered to publish a strategy for improving the conservation and management of a protected site (a protected site strategy).

(21) local authorities in England must consult before felling street trees.

Further Border Control Delays (UK)

The UK government recently announced that movement of goods from GB to Northern Ireland (occurring under the grace arrangements in the Northern Ireland Protocol – NIP) would continue in the current manner indefinitely.

The UK government also recently announced that CE marked goods would continue to circulate in GB for the entire 2022. CE marked goods circulate in Northern Ireland by virtue of the NIP. This was included in the August Email Alert.

This morning, the UK government confirmed – here

• The requirement for pre-notification of agri-food imports will be introduced on 1 January 2022 as opposed to 1 October 2021.

• The new requirements for Export Health Certificates, which were due to be introduced on 1 October 2021, will now be introduced on 1 July 2022.

• Phytosanitary Certificates and physical checks on SPS goods at Border Control Posts, due to be introduced on 1 January 2022, will now be introduced on 1 July 2022.

• The requirement for Safety and Security declarations on imports will be introduced as of 1 July 2022 as opposed to 1 January 2022.

The timetable for the removal of the current easements in relation to full customs controls and the introduction of customs checks remains unchanged from the planned 1 January 2022.

Live Animal Exports Ban (Britain)

Being able to ban live animal exports is considered a Brexit win (although note EU Animal Health rules also moved on since 31st Dec 2020). Animal welfare is a devolved policy area. The UK and Welsh governments consulted on the matter, and the Scottish government consulted separately. The UK and Welsh governments now publish their consultation response, and this is in line with proposals by the Scottish government – here.

The proposals will not apply to journeys under 65km. The proposals are –

* A ban on the export of livestock (cattle, sheep, goats and pigs) and horses from England, Wales and Scotland for slaughter and fattening. Exports for slaughter and fattening from England, Wales and Scotland will be prohibited whether the animals originate from or are travelling through England, Wales and Scotland.

The ban will apply to all exports of livestock and horses where an animal is exported to the place of destination in order to be fattened for subsequent slaughter.

The ban will be achieved via the Animal Welfare (Kept Animals) Bill (Clause 42) – here.

The proposals also cover maximum journey times, temperature and comfort during travel and other matters. These proposals could be achieved via Statutory Instruments or guidance, or both.

Environment Bill (announced additions) (UK)

The long awaited and highly significant Environment Bill is revived in the current Parliament session. I Blog posted earlier that it would be.

The UK government has made 3 announcements in May –

(1) new legal duties on water companies and the government will be inserted to reduce sewage discharged into waterways – announcement is here

(2) a new additional legally binding target for species abundance for 2030 will be inserted – George Eustice Speech is here

Environmental targets in the Bill are summarised in the October 2020 updated August 2020 policy paper – here.

(3) a new power will be taken to refocus the Habitats Regulations – see George Eustice Speech

[The George Eustice Speech also makes further announcements on consultation and strategy publication in the areas of Nature, Peat and Trees.]

The Bill, as we see it now, was originally revived from the previous May Government after the 2019 general election.

In 2020, the majority of the 2019-2020 Bill provisions were substantially the same as its predecessor, although a number of minor technical changes had been made to the drafting. The substantive additions to the Bill (at the start of 2020) were :

• a requirement on Ministers to make a statement to Parliament setting out the effect of new primary environmental legislation on existing levels of environmental protection (Clause 19); and

• a requirement on the Secretary of State to conduct a two-yearly review of the significant developments in international legislation on the environment, and to publish a report on their findings every two years (Clause 20).

The Commons Library analysed the Environment Bill in March 2020 – here.

Most of the Bill extends to England and Wales and applies in England. There are some parts that extend to the whole of the UK or apply to specific UK nations. For example, there are specific provisions on environmental governance, managing waste and water quality that extend and apply to Northern Ireland only. Provisions on waste including producer responsibility, resource efficiency and exporting waste extend and apply to the whole of the UK, as do the provisions on environmental recall of motor vehicles, and the provisions on the regulation of chemicals.

Note – DEFRA has current consultations relating to the Environment Bill –

(1) Consultation on the Draft Policy Statement on Environmental Principles – here.

(2) Consultation on Introducing a Deposit Return Scheme in England, Wales and Northern Ireland (a Deposit Return Scheme is already legislated for in Scotland) – here.

SPS Export Health Certificates from April 21 (EU)

I posted before about the new EU Animal Health Law (Regulation (EU) 2016/429) that comes into force on April 21. This document is here.

The new EU Animal Health Law (AHR) is a large and complex Regulation designed to consolidate, update and replace a number of existing Regulations.

The main change is the new model export health certificates (EHCs) in use from April 21. EHCs are required for third country import into the EU.

AT THE SAME TIME, April 21 is the date for new rules for entry into the EU of composite products.

Including those for composites, a total of five new EHCs are needed from 21 April. These include three new products of animal origin (POAO) EHCs, two new composite EHCs and a private attestation document for composites exempt from certification. In the UK, private attestations do not need to be signed by an Official Veterinarian (OV) or Food Competent Certifying Officer (FCCO).

The three new POAO EHCs include meat of certain wild game and farmed large game and mechanically separated pork meat.

The two new composite product EHCs are –

a. Entry into the EU (or Northern Ireland) of not shelf-stable composite products and shelf stable composite products, containing any quantity of meat products (except gelatine, collagen and highly refined products) and intended for human consumption; and,

b. Transit through the EU to a third country either by immediate transit or after storage in the Union of not shelf-stable composite products and shelf-stable composite products containing any quantity of meat products and intended for human consumption.

Article 12 of Commission Delegated Regulation (EU) No 2019/625 (delegated rules to a DIFFERENT Regulation (EU) No 2017/625, the Official Controls Regulation) establishes three categories of composite products (applicable from April 21):

(1) non shelf-stable composite products,

(2) shelf-stable composite products that contain any quantity of meat products, except gelatine, collagen and highly refined products, and

(3) shelf-stable composite products that do not contain meat products, except gelatine, collagen and highly refined products.

Note: the EU Official Controls Regulation itself has applied since 14 December 2019.

With a view to smoothen the transition, Article 35 of Commission Implementing Regulation (EU) No 2020/2235 introduces a period of six months (to 20 October 2021) for the imports of composite products during which the old certificate will be accepted to enter the Union. Where no certificate was required prior to 21 April 2021, then the new relevant certificate or private attestation must be provided.

What is not a composite product?

The addition of a product of plant origin during the processing defined in Article 2(1)(m) of Regulation (EC) No 852/2004 of an animal product does not automatically mean that the resulting food falls within the definition of composite products. If such addition does not modify the main characteristics of the final product, the latter is not a composite product. It can be to add special characteristics or necessary for the manufacture of the product of animal origin (Article 2(1)(o) of Regulation (EC) No 852/2004).

For instance, a cheese to which herbs are added or a yogurt to which fruit is added remain dairy products. Similarly, canned tuna to which vegetable oil is added remains a fishery product. These foodstuffs must be produced in approved establishments in accordance with Regulation (EC) No 853/2004.

What percentage of a processed product of animal origin makes a food subject to the rules applicable to composite products?

What makes foodstuff subject to the rules applicable to the composite products is the fact that it is made by both products of vegetable origin and processed products of animal origin. The percentage of processed product of animal origin included in the composite product is irrelevant.

The above is taken from the EU Q&A on composite products – here.

These changes create a high impact on food trade between the UK and the EU.

From April 21, any composite product containing meat products (except gelatine, collagen and highly refined products) is subject to EU Border Control Post (BCP) (or Points of Entry (PoE) for Northern Ireland) checks and requires an EHC.

Chilled/frozen composite products containing processed dairy/egg/fish require EU BCP/PoE checks and an EHC.

Shelf stable composite products containing processed dairy/egg/fish (where the dairy or egg components meet certain heat treatment requirements) require a private attestation and EU BCP/PoE checks unless they are on the EU’s list of lower risk products.

The UK has updated its composites products guidance – here.

APHA (a DEFRA agency) has produced guidance on the April 21 changes – here.

It will be noted that guidance in the EU and the UK is not yet updated in all areas.

The EU is yet to publish the final EHCs for live animals and germinal products that will be used under the AHR. All EU EHCs and Notes for Guidance are being updated to reflect the new rules by August 2021. Only those needed for use by traders from 21 April will be available from April on EHC Online (EHCO), with the remainder uploaded and available by August 2021.

UK updates to the TCA (Britain)

A little while ago, the Government announced (unilateral) new dates for the grace periods applying to GB goods movement to Northern Ireland under the IRl/NI Protocol. The Brexit Guidance was then updated.

The Government has now announced (unilateral) new dates for the grace periods applying to EU imports into Britain under the TCA (the UK-EU FTA). The Brexit Guidance will be updated.

We are announcing today a clear revised timetable for the introduction of controls, as follows:

• Pre-notification requirements for Products of Animal Origin (POAO), certain animal by-products (ABP), and High Risk Food Not Of Animal Origin (HRFNAO) will not be required until 1 October 2021. Export Health Certificate requirements for POAO and certain ABP will come into force on the same date.

• Customs import declarations will still be required, but the option to use the deferred declaration scheme, including submitting supplementary declarations up to six months after the goods have been imported, has been extended to 1 January 2022.

• Safety and Security Declarations for imports will not be required until 1 January 2022.

• Physical SPS checks for POAO, certain ABP, and HRFNAO will not be required until 1 January 2022. At that point they will take place at Border Control Posts.

• Physical SPS checks on high risk plants will take place at Border Control Posts, rather than at the place of destination as now, from 1 January 2022.

• Pre-notification requirements and documentary checks, including phytosanitary certificates will be required for low risk plants and plant products, and will be introduced from 1 January 2022.

• From March 2022, checks at Border Control Posts will take place on live animals and low risk plants and plant products.

Traders moving controlled goods into Great Britain will continue to be ineligible for the deferred customs declaration approach. They will therefore be required to complete a full customs declaration when the goods enter Great Britain.

Controls and checks on Sanitary and Phytosanitary goods are of course a devolved matter and we continue to work closely with the Devolved Administrations on their implementation, in particular with the Welsh Government on their timetable for completing supporting Border Control Post infrastructure in Wales.

The written statement is here.

GB goods movement to the EU is unaffected, i.e. the TCA applies in full.

Plastic Waste Shipment (EU)

On 22nd December 2020 the EU adopted new rules on the export, import and intra-EU shipment of plastic waste – here. [these changes are not yet in the CONSLEG consolidated law version uploaded on Cardinal Environment EHS Legislation Registers & Checklist, and the updated law will be added shortly]

The new rules ban the export of plastic waste from the EU to non-OECD countries, except for clean plastic waste sent for recycling. Exporting plastic waste from the EU to OECD countries and imports in the EU will also be more strictly controlled.

The new rules entered into force on 1 January 2021. They apply to exports, imports and intra-EU shipments of plastic waste: [see below per the EU news announcement]

Exports from the EU

• Exporting hazardous plastic waste and plastic waste that is hard to recycle from the EU to non-OECD countries will be banned.

• Exporting clean, non-hazardous waste (which is destined for recycling) from the EU to non-OECD countries will only be authorised under specific conditions. The importing country must indicate which rules apply to such imports to the European Commission. The export from the EU will then only be allowed under the conditions laid down by the importing country. For countries which do not provide information on their legal regime, the “prior notification and consent procedure” will apply.

• Exporting hazardous plastic waste and plastic waste that is hard to recycle from the EU to OECD countries will be subject to the “prior notification and consent procedure”. Under this procedure, both the importing and exporting country must authorise the shipment.

Imports into the EU

• Importing hazardous plastic waste and plastic waste that is hard to recycle into the EU from third countries will be subject to the “prior notification and consent procedure”. Under this procedure, both the importing and exporting country must authorise the shipment.

Intra-EU shipments

• The “prior notification and consent procedure” will also apply to intra-EU shipments of hazardous plastic waste, and of non-hazardous plastic waste that is difficult to recycle.

• All intra-EU shipments of non-hazardous waste for recovery will be exempt from these new controls. 

These new rules amend the EU’s Waste Shipment Regulation (EU Waste Transhipment Regulation) and implement the decision taken by 187 countries in May 2019 at the Conference of the Parties of the Basel Convention. This Basel decision set up a global regime governing international trade in plastic waste for the first time, by including new entries on plastic waste in the Annexes of the Convention.

The EU ban on exports outside the OECD of plastic waste that is difficult to recycle, goes further than the requirements of the Basel Convention.

[Note: the UK is outside the EU, it did update its International Waste Shipment Regulation to incorporate a prior notification and consent process effective 1st Jan 2021 – see Cardinal Environment Registers and Checklists – but it did not implement a ban on exports of plastic waste to non-OECD. DEFRA – The government had “pledged to ban the export of all plastic waste to non-OECD countries”, but no timetable for action exists. Research is commissioned to better understand existing UK plastic waste recycling capacity and DEFRA would consult in due course on how to deliver its manifesto commitments.]

GMO Regulation Changes (England)

In its first Brexit de-regulation foray (of relevance to this blog) – the UK government today seeks views on its plans to change its regulation of genetically modified organisms (GMOs) in England – here.

The consultation ends on 17 March 2021.

Part 1 of the consultation focuses on the regulation of gene edited (GE) organisms possessing genetic changes which could anyway have been introduced by traditional breeding.

Part 2 of the consultation engages separately and starts gathering views on the wider regulatory framework governing genetically modified organisms (GMOs).

Depending on the results of part 1, DEFRA may change the legislation to amend the definition of a GMO as it applies in England. Currently GMOs are defined in section 106 of the Environmental Protection Act 1990 (amended by the GMO Deliberate Release Regulations). This would mean that the law would not apply to organisms produced by gene editing (GE) and other genetic technologies if they could have been developed using traditional breeding methods. DEFRA’s view is that organisms produced by GE or by other genetic technologies should not be regulated as GMOs if they could have been produced by traditional breeding methods.

The responses from part 2 of the consultation will be used by the UK government to inform policy development and stakeholder engagement plans on any potential wider GMO reform.

On 25 July 2018 the Court of Justice of the European Union (CJEU) clarified that organisms obtained by mutagenesis are genetically modified organisms (GMOs) as defined in the European Directive 18/2001/EC. The journal Nature has a useful summary article on this technical field – here.

Note – the Court also clarified that organisms obtained by mutagenesis techniques which have conventionally been used in a number of applications and have a long safety record are exempt from those obligations, on the understanding that the Member States are free to subject them, in compliance with EU law, to the obligations laid down by the directive or to other obligations.

The ECJ Press Release on the matter is here.

F-Gases and ODS (Northern Ireland from 1 Jan 2021)

DEFRA has today, 15 Oct, issued stipulations for F-Gases and ODS in Northern Ireland – here.

After the end of the transition period, EU regulations will continue to apply to all businesses in Northern Ireland who produce, supply, import, export or use F gases or ODS.

This means two changes for businesses in Northern Ireland:

• Businesses who import and supply the Northern Ireland market with F gases or equipment containing F gas will need to have enough EU quota/authorisations to cover their imports from Great Britain, if they do not already have this. Engineers and end-users, such as equipment manufacturers, installers and supermarkets, working with F gas should ensure they get their F gas from someone that has EU quota.

• F gas and ODS technicians in Northern Ireland will need to qualify for an Irish certificate if they are to continue working in the Republic of Ireland from January 2021. However, they will be able to continue to work in Northern Ireland with their current certificate.

The new free-to-use Trader Support Service will provide support and guidance to businesses moving goods under the Northern Ireland Protocol. Businesses who sign up to the Trader Support Service will be guided through the new processes under the Northern Ireland Protocol and can also use it to complete digital declarations.

Please also read the stipulations that apply to GB, including GB quotas, set out in separate instructions – here.