Equal Pay Proposal (EU)

On 4th March, the European Commission presented a proposal on pay transparency – here.

The legislative proposal focuses on two core elements of equal pay:

(1) measures to ensure pay transparency for workers and employers, and

(2) better access to justice for victims of pay discrimination.

Further information is here.

NB: this Blog does not focus on Employment Law issues.

Medical Devices Regulation (EU)

The new EU Medical Devices Regulation 2017/745 (MDR) applies from (yesterday) 26 May, after a year’s postponement. The MDR is here.

The MDR tightens controls on high-risk devices such as implants and requires the consultation of a pool of EU level experts before placing medical devices on the market. Clinical evaluations, investigations and the notified bodies that approve the certification of medical devices will be subject to tighter controls.

The new European database of medical devices (EUDAMED) will contain information about each medical device on the market, including economic operators and certificates issued by notified bodies. Each device will have a unique device identifier so that it can be found in EUDAMED. Labelling will be more detailed and electronic manuals will increase user-friendliness. Implant patients will receive an implant card with all the essential information.

Once devices are available on the market, manufacturers will have to collect data about the devices’ performance. EU countries will closely coordinate their vigilance and market surveillance.

The MDR is complemented by the Regulation on in vitro diagnostic medical devices (2017/746/EU) which applies a year later on 26 May 2022.

Q&A about the MDR is here.

European Climate Law (EU)

I blog posted before (in December) about the EU’s proposal for a European Climate Law. On 21 April, the EU’s co-legislators reached provisional agreement on the matter.

The European Climate Law will contain the EU’s commitment to reaching climate neutrality by 2050 and the intermediate target of reducing net greenhouse gas emissions by at least 55% by 2030, compared to 1990 levels.

Once this provisional agreement is formally approved by Parliament and Council, the European Climate Law will be published in the Official Journal of the Union and will enter into force.

Further information is 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.

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]