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.

5th List of Occupational Exposure Limits (EU)

Directive 2019/1831 (amending Directive 2000/39/EC) establishes a fifth list of indicative occupational exposure limits (IOELVs) for chemical agents.

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 Union limit value determining the nature of the national limit value in accordance with national legislation and practice.

Member States must bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20th May 2021 at the latest.

The Directive establishes limit values for the following chemical agents:

Aniline

Chloromethane

Trimethylamine

2-Phenylpropane (Cumene)

sec-Butyl acetate

4-aminotoluene

Isobutyl acetateIsobutyl acetate

Isoamyl alcohol

n-Butyl acetate

Cardinal Environment EHS Legislation Registers & Checklists will be updated shortly.

EU Drinking Water Directive (EU)

The current Drinking Water Directive 98/83/EC last amended in 2015, is replaced by a new Drinking Water Directive (EU) 2020/2184 in force 12th January 2021. Member states have two years to bring in national legislation. We will add this Directive to Cardinal EHS Legislation Registers &a Checklists shortly.

The new EU Drinking Water Directive is here.

Key features of the revised Directive are:

• Reinforced water quality standards which are more stringent than WHO recommendations.

• Tackling emerging pollutants, such as endocrine disruptors and PFA’s, as well as microplastics – for which harmonised analytical methods will be developed in 2021.

• A preventive approach favouring actions to reduce pollution at source by introducing the “risk based approach”. This is based on an in-depth analysis of the whole water cycle, from source to distribution.

• Measures to ensure better access to water, particularly for vulnerable and marginalised groups.

• Measures to promote tap water, including in public spaces and restaurants, to reduce (plastic) bottle consumption.

• Harmonisation of the quality standards for materials and products in contact with water, including a reinforcement of the limit values for lead. This will be regulated at EU level with the support of the European Chemicals Agency (ECHA).

• Measures to reduce water leakages and to increase transparency of the sector.

Changes to Energy Labels and Ecodesign (EU)

1 March 2021 was the date for repeal and replacement of some of the pre-existing EU Regulations on both Energy Labels and Ecodesign.

15 product groups require an energy label, and 31 product groups are subject to ecodesign requirements – here.

Industry sectors may also sign voluntary agreements to reduce the energy consumption of their products. The European Commission formally recognises such agreements and monitors their implementation. 

The new Energy labels set out a different energy efficiency scale.

The new Ecodesign stipulations include requirements for repairability and availability of spare parts.

EU REACH lead shot ban (EU)

25 Jan 2021 amendment to EU REACH – here – bans lead shot in or around wetlands. The amendment is made to EU REACH Annex XVII (the marketing and use restrictions).

From 15 February 2023, a list of activities involving use of lead shot in or within 100 metres of wetlands is banned.

“wetlands” means areas of marsh, fen, peatland or water, whether natural or
artificial, permanent or temporary, with water that is static or flowing, fresh, brackish or salt, including areas of marine water the depth of which at low tide does not exceed 6 metres.

Reaction to this ban is here.

In addition, ECHA (the European Chemicals Agency) has published its proposals for further restrictions on the use of lead in ammunition for hunting, outdoor sports shooting and fishing.

The ECHA proposals are described and found here.

New Animal Health Law (EU)

From 21st April 2021, the EU will operate a new single, comprehensive regulatory framework for animal health, replacing a miscellany of complex law. The instrument (amended in 2017) is here. It’s a 2016 dated EU Regulation 2016/429, and applies to terrestrial and aquatic animals, animal products, and pets. It does not directly deal with animal welfare.

Q&A on the EU Animal Health Law is here.

The EU Animal Health Law sets out requirements for:

• disease prevention and preparation (e.g. biosecurity measures) for eventual outbreaks, such as the use of diagnostic tools, vaccination and medical treatments;

• the identification and registration of animals and the certification and tracing of their consignments, as well as those of certain animal products (e.g. semen, ova, embryos);

• the entry of animals and animal products into the EU and movement within;

• disease control and eradication, including emergency measures such as restrictions on the movement of animals, killing and vaccination.

The EU’s Animal Health Law is supplemented in the following aspects:

• the approval of germinal product establishments and the traceability and animal health requirements for movements within the EU of germinal products of certain kept terrestrial animals;

• prevention and control of certain diseases;

• animal health requirements for the movements within the EU of terrestrial animals and hatching eggs;

• surveillance, eradication and disease free status for certain diseases;

• rules for aquaculture establishments and transporters of aquatic animals;

• rules for entry into the EU, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin; and

• rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs;

• diseases subject to union surveillance programmes, its geographical scope and diseases for which disease-free status of compartments may be established.

A series of delegated Regulations and an implementing Regulation supplement the EU Animal Health Law.

Safety Data Sheets (SDS) (EU)

Safety data sheets are regulated in the EU (and the EEA) via article 31 and Annex II of EU REACH.

In 2020, an amendment was made to EU REACH, that changed the safety data sheet requirements and the SDS format, effective 1st Jan 2021.

The instrument that does this is here. The SDS guidance was re-issued here.

Safety data sheets not complying with this 2020 change may continue to be provided until 31 December 2022.

The new EU SDS will apply to all goods circulating in the EU and in Northern Ireland.

[this change is not incorporated in UK REACH]

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.]

European Climate Law (EU)

Today saw the publication of the conclusions of the December meeting of the European Council. On the matter of Climate Change, the European Council endorsed a binding EU target of a net domestic reduction of at least 55% in greenhouse gas emissions by 2030 compared to 1990, tasking the co-legislators to reflect this new target in the European Climate Law proposal and to adopt the latter swiftly.

The EU’s nationally determined contribution (NDC) will be updated according to the new binding target and submitted to the UNFCCC secretariat by the end of the year (ahead of COP 26 – the 2021 UN Climate Change Conference).

Information on the European Climate Law is here. (note, it’s a proposal)

Ecodesign – External Power Supplies (EU)

A 2009 dated EU Directive 2009/125/EC establishes a framework for the setting of ecodesign requirements for energy-related products. Separate EU Regulations set ecodesign specifies for individual product groups within this framework.

A 2009 dated EU Regulation (EC) No 278/2009 set the ecodesign requirements for external power supplies, and this is now reviewed and updated.

EU Regulation (EU) 2019/1782 now sets the new ecodesign requirements for external power supplies from 1st April 2020 (and Regulation (EC) No 278/2009 is repealed from that date). The new EU Regulation is here. It specifies energy efficiency requirements.

EU Regulation (EU) 2019/1782 applies to all external supplies as defined in Article 2, except a short list set out in Article 1.

The updated European Regulation applies to the EU member states, including the UK (where it will be regarded as Retained EU Law).