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

Nuclear Safety Standards (Euratom/EU)

I blog posted recently about the UK Nuclear Safeguards Bill (a UK Brexit Bill). This Bill does not cover radiation health rules (which are also regulated by EU/Euratom). 

The Euratom/European Union Basic Safety Standards Directive 2013 (BSSD) sets out updated safety requirements for the nuclear and radiological sector; the deadline for transposition of these into UK law is 6 February 2018

The BSSD 2013 updates the 1996 BSSD that is included in subscribers’ Cardinal Environment OHS Register 601. It simplifies existing Euratom provisions for protection against harmful effects of ionising radiation, and consolidates those provisions in line with the latest international standards.

The UK Department for Business, Energy and Industrial Strategy (BEIS) is responsible for coordinating the transposition of the Directive across Government, there are five workstreams to the Directive: emergency preparedness and response, medical exposures, public exposures, occupational exposures, and air and space crew where compliance is necessary.

The emergency response and public exposures requirements of BSSD are led by BEIS and occupational exposure requirements are led by the Health and Safety Executive (HSE).

The intention is to use the powers in the Health and Safety at Work Act and the Energy Act 2012 to make the required legislative changes within the Radiation (Emergency Preparedness and Public Information) Regulations (REPPIR) 2001 and the Carriage of Dangerous Goods Regulations (CDG) 2009 and the Ionising Radiation Regulations 1999 (IRR99).

HSE has now consulted on occupational exposures policy and are finalising the proposed changes to the IRRs (this document is here); BEIS has launched a consultation on emergency preparedness and response policy with suggested changes to REPPIR & CDG (see here). BEIS is also planning to launch a consultation on the public exposures elements of the Directive.

The other workstreams are led by different Government departments, with medical exposures being led by the Department for Health and air and space crew by the Department for Transport.

Re Brexit : it is presumed these rules will be dealt with under the EU Withdrawal Bill (a key UK Brexit Bill), once it is enacted, since they are not dealt with under the Nuclear Safeguards Bill. 

Subscribers to Cardinal EHS Legislation Registers will see Email Alerts re the changes to the CDG and IRR99. 

Endocrine Disruptors (EU)

On the 4th July 2017, EU Member States voted in favour of draft criteria to define endocrine disruptors in the area of plant protection products. These draft criteria are here. The criteria are based on the WHO definition of an endocrine disruptor, and apply to human health and also to the environment. 

The criteria will apply after a short transitional period of 6 months. 

EU legislation provides that active substances used in plant protection products are only approved for a limited period of time, and that these approvals are routinely reviewed. EU legislation for plant protection products also provides that active substances which are endocrine disruptors shall not be approved, unless there is negligible exposure in which case they may be approved under restricted conditions.

As regards the criteria for the environment, the specificity of some active substances which have endocrine modalities that affect target arthropods (e.g. insects) but do not affect vertebrates including humans has been acknowledged. These substances, of particular interest for integrated pest management, will be subjected to a specific risk assessment and only approved if there are no unacceptable effects on non-target organisms.

The question whether an active substance is an endocrine disruptor will be assessed each time the substance is subject to an approval or a renewal of approval at EU level.

The legal text setting out the criteria has been sent to the Council and the European Parliament. They will have three months (from July) to examine it before final adoption by the Commission. The text will enter into force 20 days after its publication in the Official Journal and be applicable six months after this (see above). 

In order to be ready to apply the criteria, EFSA and ECHA are preparing a joint Guidance document on endocrine disruptors. An outline was published on 20 December 2016 and a draft guidance document – already consulted with Member States and stakeholders – will be available for public consultation in autumn. After this public consultation, the guidance document will be finalised before the criteria start applying. It is important to recall that the criteria will apply also to the on-going procedures reassessing the substances. This post will be updated at that point. 

Further information is set out in this European Commission press release. Here

Energy efficient products (EU)

In the European Union, many everyday products such as washing machines, refrigerators, domestic boilers and cooking appliances carry energy labels and are designed to meet minimum energy efficiency standards.

Energy labels help consumers choose energy efficient products. Hitherto, the labelling requirements for individual product groups have been created under the EU’s Energy Labelling Directive, a process managed by the European Commission. Products had been labelled on a scale of A+++ (most efficient) to G (least efficient).

In July 2017, a new Energy Labelling Regulation was published that will gradually replace the Directive. In the future, products will be labelled using a simpler A to G scale, as the development of more energy efficient products means that the lowest categories in the previous scale are no longer needed. Consumers will also have access to a database of product labels and information sheets, and defeat devices, which alter a product’s performance under test conditions, will be banned.

The new Energy Labelling Regulation is here. It is in force from 1st August 2017. As a European Regulation it is directly applicable in all member States, without necessary enactment of local law. 

Companies can create their own labels for energy efficiency using a range of labelling tools.

Ecodesign regulations require manufacturers to decrease the energy consumption of their products by establishing minimum energy efficiency standards. By setting these standards at European level, manufacturers do not have to navigate through multiple national regulations when launching their products on the market.

The ecodesign requirements for individual product groups are created under the EU’s Ecodesign Directive, process also managed by the European Commission. As an alternative, industry sectors may sign voluntary agreements to reduce the energy consumption of their products. The Commission formally recognises such agreements and monitors their implementation.
The (recast) European Directive (dating 2009) is here

It is in the UK news that energy inefficient and noisy vacuum cleaners are banned from today (1st Sept 2017), this is the date set out by the vacuum cleaner specific European Regulation made under the EU’s Ecodesign Directive. The European Regulations issued for products covered by the Ecodesign Directive are located from this link

The European ENERGY STAR Programme is a voluntary energy labelling scheme for office equipment. With the ENERGY STAR logo, consumers can easily identify energy efficient products. It covers office equipment including computers, servers, displays, imaging equipment and UPSs.

ENERGY STAR was started by the US Environment Protection Agency in 1992. The EU agreed to take part in 2001 to include office equipment not carrying an EU energy efficiency label.

Under EU law (Article 6 and Annex III (c) of Directive 2012/27/EU), central governments and EU institutions must purchase office equipment with energy efficiency levels at least equivalent to ENERGY STAR.

Vehicle type approvals (EU)

From 1st September 2017, new car models will have to pass new and more reliable emissions tests in real driving conditions. 

The EU press release is here.

Please note the EU has initiated infringement proceedings (enforcement actions) against a number of member states including the UK, for their failure to fulfill their obligations under EU vehicle type approval legislation. 

The EU press release is here.

The European Commission is also working to ensure the application of EU air quality rules. In this regard, it has launched infringement procedures against 16 Member States in breach of ambient NO2 limit values.