Personal Protective Equipment (EU)

Existing PPE Directive 89/686/EEC covers the manufacture and marketing of personal protective equipment. It defines legal obligations to ensure that PPE on the European market provides the highest level of protection against hazards. The CE marking affixed to PPE provides evidence of this protection. Manufacturers or their authorised representative in the EU comply with the technical requirements directly or with European Harmonised Standards. The latter provides a presumption of conformity to the essential health and safety requirements.

Applicable 21 April 2018, Directive 89/686/EEC is repealed by the new Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment – here.

The new PPE Regulation is aligned to the EU’s New Legislative Framework policy. In addition, it slightly modifies the scope (enlarged to include PPE designed and manufactured for private use to protect against heat) and the risk categorisation of products. It also clarifies the documentary obligations of economic operators.

As a European Regulation (not a Directive) it is directly binding on a Member State (and on operators marketing to a Member State) without enactment of national law (although national law may be additionally enacted).

Brexit : PPE is covered by the EU Notice on Industrial Goods here. (I have posted a number of times with links to EU Notices)

Brexit in the UK, this new EU PPE Regulation applies from 21 April 2018, after Brexit it applies via the EU (Withdrawal) Bill. NB: the EU (Withdrawal) Bill is not yet enacted.

Subscribers to Cardinal Environment EHS Legislation Registers and Checklists will be sent an Email Alert of the addition of this new EU Regulation to the PPE Register and Checklist component in their websystems.

General Data Protection Regulation (EU)

The General Data Protection Regulation (2016/679) is here. Article 5 sets out the principles.

This GDPR applies from 25th May 2018 and overrides national law (although in some instances new national law may additionally be brought in).

[Brexit : the GDPR applies in the UK from 25th May 2018 – after Brexit, the GDPR will apply in the UK via the EU (Withdrawal) Bill – see separate Blog post – the EU (Withdrawal) Bill is not yet enacted]

[UK : separately (and not to be confused) a new UK Data Protection Bill is almost enacted – see Explanatory Notes here]

The general data protection regulation (GDPR) is part of the EU data protection reform package.

Features

• a single set of EU-wide rules — it repeals the pre-existing European Directive 95/46/EC;

• a data protection officer, responsible for data protection, must be designated by public authorities and by businesses which process data on a large scale;

• one-stop-shop — businesses will deal with one single supervisory authority (in the EU country in which they are mainly based);

• EU rules for non-EU companies — companies based outside the EU must apply the same rules when offering services or goods, or monitoring the behaviour of individuals, within the EU;

• privacy-friendly techniques must be used, such as pseudonymisation (when identifying fields within a data record are replaced by one or more artificial identifiers) and encryption (when data is coded in such a way that only authorised parties can read it);

• removal of notifications — the new data protection rules will scrap most notification obligations and the costs associated with these, one of the aims of the data protection regulation is to remove obstacles to free flow of personal data within the EU;

• impact assessments — businesses must carry out impact assessments when data processing may result in a high risk for the rights and freedoms of individuals;

• record-keeping — SMEs are not required to keep records of processing activities, unless the processing is regular or likely to result in a risk to the rights and freedoms of the person whose data is being processed.

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The UK Information Commissioner’s Office (ICO) has a useful updated guide in English here.

ICO guidance for small organisations is here.

Plastic Strategy (EU)

The EU has adopted today (16th January 2018) its first plastic strategy. The press release is here. The Q&A is here.

Next Steps

The new Directive on port reception facilities proposed today will now go to the European Parliament and Council for adoption.

Subject to Better Regulation requirements, the Commission will present the proposal on single-use plastics later in 2018.

Stakeholders have until 12 February 2018 to contribute to the ongoing public consultation.

The Commission will launch the work on the revision of the Packaging and Packaging Waste Directive and prepare guidelines on separate collection and sorting of waste to be issued in 2019.

For the full list of measures and their timeline, see the Annex to the Plastics Strategy here.

A few remarks (in the UK Brexit context)

(1) I posted a few days ago about imminent changes to 6 EU Waste Directives (the EU Circular Economy Package). The new rules will fix a new target of 55% recycling of plastic packaging waste by 2030, set a ban on landfilling separately collected waste and fix stronger arrangements for extended producer responsibility (EPR) schemes. It is not announced if the UK will follow this.

(2) The EU Plastic Strategy identifies that by 2030 all plastic packaging should be designed to be recyclable or reusable. To achieve this, the European Commission will work on a revision of the legislative requirements for placing packaging on the market. The revision process will focus on defining the concept of design for recyclability. The goal is to decrease the quantity of waste generated and to avoid that these materials end up as litter, are incinerated or are landfilled where can be recycled. This also includes the issue of over-packaging. It is not announced if the UK will follow this (the commitment in the UK 25-yr environmental plan is to eliminate plastic waste where practicable by 2042).

(3) Microplastics are plastic particles smaller than 5 mm. They end up in the surface waters and the marine environment, either because they are used intentionally in products in order to accomplish a certain function (e.g. microbeads in cosmetics as exfoliating agents) or because they are generated through the breakdown of larger plastic pieces and through the wear and tear of products (e.g. through abrasion of tyres or washing of textiles).

The European Commission has started work to restrict the use of microplastics that are intentionally added in products through the Registration, Evaluation, Authorisation and Restriction of Chemicals regulation (REACH).

Regarding unintentional release of microplastics, the European Commission is examining options such as labelling, minimum requirements for product design and durability, methods to assess quantities and pathways of microplastics in the environment, funding for targeted research and innovation.

The UK Government has brought in Microbeads Regulations applicable in England. I posted earlier about this, and Email Alerts have been sent (if you did not receive an Email Alert, and need the legislation adding to your EHS Legislation and Law Checklists, please let me know).

(4) The EU Plastic Strategy proposes to look into actions to specifically tackle single-use plastic items and other marine litter, including lost or abandoned fishing gear. Preparatory work has started on a legislative initiative on single-use plastics to be tabled by the European Commission, following the approach already used to tackle light-weight plastic bags.

The results of an ongoing public consultation will help determine the measures to be taken. The UK 25-yr environment plan contains proposals on single-use plastics, but not specifically on fishing gear.

(5) A 2015 amendment of the European Packaging and Packaging Directive mandated Member States to address plastic bag use – see article 4(1a) in the Directive itself here. The UK brought in Legislation in all UK jurisdictions (prior to the 2015 Directive amendment being agreed) and recently signalled it would remove the exemptions that were applied in England.

Note : the provisions of article 8a in the Packaging and Packaging Waste Directive which relate to the labelling and identification of biodegradable and compostable plastic carrier bags, the implementation period (for Member States) is 18 months from the date of that separate 2017 European instrument.

Waste (EU)

UPDATE : the European Parliament has approved the proposals, the package of changes will now be submitted to the Council for final adoption, and will enter into force 20 days after publication in the Official Journal.

The European Parliament approved a slightly different package to the 2015 proposals, details are here.

Background

In 2015 the European Commission proposed revisions to existing EU waste law. Four new revising EU Directives were proposed (known as the Circular Economy Package) :

(1) revision to the EU Waste Directive

(2) revision to the EU Packaging and Packaging Waste Directive

(3) revision of the EU Landfill Directive

(4) revision of the EU End-of-life Vehicles Directive, the Batteries and Waste Batteries Directive, and The WEEE Directive.

Key elements of the 2015 waste proposal are:

  • A common EU target for recycling 65% of municipal waste by 2030;
  • A common EU target for recycling 75% of packaging waste by 2030;
  • A binding landfill target to reduce landfill to maximum of 10%of municipal waste by 2030;
  • A ban on landfilling of separately collected waste;
  • Promotion of economic instruments to discourage landfilling;
  • Simplified and improved definitions and harmonised calculation methods for recycling rates throughout the EU;
  • Concrete measures to promote re-use and stimulate industrial symbiosis –turning one industry’s by-product into another industry’s raw material;
  • Economic incentives for producers to put greener products on the market and support recovery and recycling schemes (eg for packaging, batteries, electric and electronic equipment, vehicles).

Provisional agreement was reached in December 2017 in the final stage of the EU law making process :

* Revised common EU targets for municipal waste recycling – at least 55% by 2025, 60% by 2030, 65% by 2035,

* 10% cap on landfill by 2035,

* provisions for countries to restrict the use of single-use plastics,

* improvements in the traceability of hazardous substances in products and waste,

* decontamination of hazardous waste,

* restrictions on oxo-degradable plastics and planned obsolescence.

The final analysis of the agreed text will take place under the new Bulgarian presidency (that has commenced in January 2018) with a view to confirm the agreement.

After formal approval, the new legislation will be submitted to the European Parliament for a vote at first reading and to the Council for final adoption.

The new laws will come into force in 2018 and will then need to be transposed to into national legislation.

THIS POST WILL BE UPDATED WHEN THE AGREED LAW TEXT IS PUBLISHED – the revised EU laws will be loaded into EHS Legislation Registers at that point.

New Plant Health Regulation (EU)

Regulation (EU) 2016/2031 is a new European Plant Health Regulation, which entered into force on 13th December 2016, and is a major overhaul of the EU’s Plant Health legislation that has been in place since 1977. It will repeal and replace seven Council Directives on harmful organisms and will become fully applicable on 13 December 2019. The new Regulation is here

It focuses particularly on the prevention of entry or spread of plant pests within the EU territory, and sets out detailed rules for the early detection and eradication of Union quarantine pests if found present in the EU territory. These rules establish obligations for the notification of outbreaks by professional operators, surveys and multiannual survey programmes, demarcation of areas for the purpose of eradication, as well as enhanced requirements for the priority pests as described above.

Under the new Regulation, all Member States will have to immediately proceed with the eradication of a Union quarantine pest if found present in an area where it was not known to be present. This means that they will no longer be allowed to proceed unilaterally with containment, namely to skip the eradication step and simply take measures to restrict the presence of the pests in a particular area.

Details

Plant pests currently fall under different legal acts depending on their quarantine status or whether they affect the quality of plant reproductive material. The new Regulation will list all pests together, under three main categories:

Union quarantine pests: Not present at all in the EU territory or, if present, just locally and under official control (examples include Citrus black spot, which is not present in the EU, and Xylella which is present in a few specific locations only). Strict measures must be taken to prevent their entry or further spread within the EU due to their increased risk for plant health. These pests have to be eradicated immediately if detected.

Protected zone quarantine pests: Present in most parts of the Union, but still known to be absent in certain demarcated areas called ‘protected zones’ (for example grape phylloxera, which is present in the territory of the EU but not in Cyprus which is designated as protected zone for this pest). These pests are thus not allowed to enter and spread within these protected zones. Measures are taken (such as prohibition or restriction of movement of commodities, surveys, etc.) to avoid the introduction of these pests into the protected zones or to ensure their eradication if found present in these zones.

Regulated non-quarantine pests: Widely present in the EU territory but, since they have an impact on the quality of the plants, plant reproductive material on the market should be guaranteed free or almost free from the pest (for example, the fungus Verticillium albo-atrum is known to be harmful to the apple production in the EU, therefore certified apple trees are not allowed to enter the EU market if more than 2% of the examined quantity is contaminated with the fungus). This way the starting quality and economic value of many agricultural crops as well as forestry and fruit plants can be ensured.

The new Regulation introduces the concept of “priority pests“. These are the Union quarantine pests with the most severe potential impacts on the economy, environment and/or society of the EU. They will be subject to enhanced measures concerning surveys, action plans for their eradication, contingency plans and simulation exercises. 

The list of these priority pests will be adopted through a delegated act, as close as possible to the date of application of this Regulation (end of 2019). It will be based on the criteria fixed by the Regulation and the assessments of the severity of the impacts of those pests.

The import of most plants and plant products from non-EU countries will in principle be allowed, subject to certain conditions. Some will be prohibited or subject to very strict requirements if a risk assessment indicates that this is necessary due to the pests they might host. The new Regulation sets out more precise rules about the risk assessment and risk management supporting such measures.

Under the new Regulation, the Commission is further required to adopt within two years a list of so-called high risk plants or plant products. The import of these commodities will be prohibited as long as no detailed risk assessment has been carried out to determine if such imports should be acceptable and, if yes, under which conditions.

All living plant material (namely entire plants, fruits, vegetables, cut flowers, seeds, etc.) will only be imported into the EU if accompanied by a phytosanitary certificate confirming their compliance with the EU legislation. The Commission will adopt within two years a list of plant materials to be exempted from that certification if they are deemed safe for the EU territory.

Finally, for specific cases where there is little experience with trade of certain plants or plant products and where related pest risks are still unknown, the new Regulation sets out the possibility to introduce temporarily phytosanitary import restrictions or even a prohibition until more scientific information becomes available. 

Imports by Passengers

In principle, passengers will no longer be allowed to introduce into the EU plants/plant products from non-EU countries if they are not accompanied by a phytosanitary certificate. However, harmonised exemptions to this general rule might be granted through a Commission implementing act, setting out the maximum quantity of plant material that might be allowed to be introduced by the passengers into the EU without phytosanitary certificate.

Plant Passports

Plant passports are the documents that accompany plants and certain plant products while moving within the Union and certify their phytosanitary health status. Under the new Regulation, all plant passports will be issued using a common format, thus facilitating their visibility and making them more easily recognisable throughout the EU.

Plant passports will now be required for the movement of all plants for planting, (under the current legislation, plant passports are required only for certain plants for planting). However, in order to avoid disproportionate administrative burdens, no plant passports will be required when the plants are transferred to non-professional consumers (e.g. in places like flower shops or other retail shops).

Professional Operators

Professional operators will have to notify any quarantine pest they find in the areas of their control. For the purpose of more efficient controls, the professional operators will have to be registered by the competent authorities. The professional operators will also have to ensure the traceability of the regulated plants/plant products they receive from and submit to other professional operators.

Professional operators will be allowed to issue plant passports, under the supervision of the competent authorities. To that purpose they will have to be authorised specifically by the authorities, subject to specific conditions.

National Authorities

Member States’ competent authorities will play a key role in the implementation of these rules. They will be responsible for activities such as surveys, eradication of outbreaks, contingency plans, simulation exercises, notification of pest occurrences, controls of imports, registration of professional operators, authorisation of professional operators to issue plant passports and other attestations.

In this respect, the new Regulation will be complemented, in the coming months, by the Regulation on Official Controls which will set out the obligations of Member States with regards to official controls and other official activities.

Why will the Regulation be applicable only in three years’ time?

To replace the existing legislation, it was decided that an EU Regulation was the right instrument, since it is directly and universally applicable throughout the EU. During the next three years, a string of delegated and implementing acts needs to be adopted. This period will also be used by competent authorities and professional operators to adjust to the new common rules.

Neonicotinoids (UK/EU)

UPDATE : the DEFRA statement is here

UK DEFRA has confirmed an article in this morning’s Guardian online – the UK will back a total EU ban on neonicotinoids. This newspaper article is here

“A total ban on insect-harming pesticides in fields across Europe will be backed by the UK, environment secretary Michael Gove has revealed. The decision reverses the government’s previous position and is justified by recent new evidence showing neonicotinoids have contaminated the whole landscape and cause damage to colonies of bees. It also follows the revelation that 75% of all flying insects have disappeared in Germany and probably much further afield, a discovery Gove said had shocked him.”

In 2013, three neonicotinoids were restricted by the EU.

Per The Guardian : “The European Commission now wants a total ban on their use outside of greenhouses, with a vote expected in December, and the UK’s new position makes it very likely to pass.”

The European Commission’s information on its regulatory activities in this area is here

UK exits the EU (EU ETS)

Background 

The EU ETS is the European Union Emissions Trading System (carbon). Large polluters such as power companies and industrial firms are obliged to pay for their carbon dioxide emissions by buying carbon permits called EU Allowances. Britain is the EU’s second-largest emitter of greenhouse gases and its utilities are among the largest buyers of carbon permits. 

Article 19(1) of European Directive 2003/87/EC requires that all emission allowances issued from 1 January 2012 onwards must be held in a central Union Registry on accounts managed by the European Union Member States.

The EU system of emission allowances registries has been operational since January 2005 and provides a standardised and secure system of electronic registries which tracks the issuance, holding, transfer and cancellation of all allowances issued under the EU ETS. Initially each EU Member State had its own emissions alllowances registry. In 2012, these registries were replaced by the single Union Registry, which provides a harmonized basis to transfer allowances across the EU.

This single registry is operated and maintained by the European Commission, and national registry administrators in all 31 countries participating in the EU ETS remain the point of contact for the representatives of more than 20,000 accounts (companies or physical persons). 31 countries participate, a few more than the EU28. 

Also the allocation processes in phase 3 of the EU ETS are performed centrally in the Union Registry, both for the allocation of allowances to stationary and aircraft operators for free and for the auctioning of allowances through the common and two ‘opt-out’ auction platforms.

The legal instrument providing specific rules on the Union Registry is the Commission Regulation (EU) No 389/2013. This Regulation applies to allowances created for the EU ETS third trading period commencing on 1 January 2013 as well as for subsequent periods, annual emission allocation units and Kyoto units. It also applies to aviation allowances to be auctioned that were created for the trading period from 1 January 2012 to 31 December 2012.

Change

Known as the EU ETS Registry Regulation, Commission Regulation (EU) No 389/2013 will be amended (by EU Regulation) to Brexit safeguard the EU ETS system during the third trading period (2013-2020). The change was agreed by the European Parliament in October, and Reuters reports yesterday it is now agreed by EU Member States. The proposal document is here

The change will provide for marking and restricting the use of allowances issued by the United Kingdom as of 1 January 2018. The proposal is that marking should distinguish United Kingdom issued allowances from other allowances. The marked allowances would then no longer be able to be surrendered in order to meet compliance obligations under the EU ETS. In essence, any carbon permits (EU allowances) issued by the UK will be void from 1 January 2018

The proposed measures apply to the auctioning of ETS allowances, the issue of free allocation by the United Kingdom and the exchange of international credits for allowances, as of 1 January 2018.

A European Commission FAQ document is issued, here