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 (Notices to Business Operators)

I posted earlier re Medicines. The European Commission has now issued Notices to Business Operators in the following areas :

(1) GMOs – the Notice is here (this post will be updated when the Q&A is available). 

(2) Biocides – the Notice is here and the Q&A is here

(3) Pesticides and Plant Protection Products – the Notice is here and the Q&A is here.

Please pay close attention as the requirements differ with each legal instrument (topic). 

Plastic Microbeads in Cosmetics Ban (UK)

UPDATE 3rd August : the 2017 Regulations are now notified to the EU and to the WTO. The EU notification gives detail, and is here

A few days ago, the DEFRA Secretary of State confirmed the UK will introduce a ban on plastic microbeads in cosmetics and personal care products. Following consultation, the proposals are summarised :

(1) the ban on manufacture (England) will start 1st Jan 2018 and the ban on sale (England) will start 30th June 2018

(2) precise definitions of “microbead”, “plastic” and “rinse-off personal care product” have been developed to clearly define the scope of the ban

(3) the scope of rinse-off products will be as set out in the consultation, but DEFRA is additionally working with the Hazardous Substances Advisory Committee (HSAC) to assess the case for addressing further categories of products

(4) Trading Standards will be the regulator to manage compliance and enforcement in England

(5) enforcement in England will be carried out through a range of sanctions including variable monetary penalties, compliance notices, stop notices and enforcement undertakings

(6) the Devolved Administrations (Scotland, Wales and Northern Ireland) will consider appropriate enforcement mechanisms, regulators and timescales according to devolution settlements.

The summary of DEFRA responses is here.

Legislation is expected by the end of 2017. This is a UK initiative, and is unconnected with the EU. 

UK exits the EU (medicines and veterinary products)

On 2nd May 2017 the European Commission and the European Medicines Agency (currently based in London) issued a Q&A document. This first list of questions and answers addresses the establishment requirements (within the EEA), and will be updated.

The document is here. From 30th March 2019 00:00 hrs (CET) the UK will be a (EEA) third country, and the following provisions will apply :

(1) marketing authorisation holders must be established in the EEA (this includes Norway, Iceland and Liechtenstein),

(2) Qualified Persons for Pharmacovigilance (QPPV) must reside and carry out their tasks within the EEA,

(3) the Pharmacovigilance System Master File (PSMF) must be located within the EEA,

(4) active substances manufactured in the UK will be considered imported active substances, 

(5) medicinal products manufactured in the UK will be considered imported medicinal products, 

(6) batch release sites (for certification) must be located in the EEA. 

New European Carcinogens and Mutagens Directive (EU)

A further stage is reached yesterday in the creation of a new EU Directive to amend the existing Directive on this topic to introduce stricter limits on exposure values and skin notations for five carcinogens as well as skin notations independently of limit values for two more carcinogens, covering seven carcinogens in total.

The carcinogenic and mutagenic substances covered by the directive are the following: Mineral Oils that have been used before in internal combustion engines, certain polycyclic aromatic hydrocarbons (PAHs) mixtures, trichloroethylene, 4,4′-methylenedianiline, epichlorohydrine, ethylene dibromide, ethylene dichloride. 

The European Commission had submitted in January 2017 the proposed revision which concerns in particular annexes I and III of directive 2004/37/EC. 

The retained limit values are based on an analysis of economic, social and environmental impacts of the different policy options for each chemical agent, on the criteria of the scientific advice of the scientific committee on occupational exposure limits (SCOEL), effectiveness, efficiency and coherence. 

The limit values were also agreed by the advisory committee on health and safety at work (ACSH). 

This revision follows an earlier Commission proposal which already included 13 carcinogenic agents.

A further package of proposed limit values is expected to be adopted by the Commission at the beginning of next year. 

The current documents are found here

TSCA Reform (Chemicals) (US)

The U.S. federal Toxic Substances Control Act (TSCA) regulates chemicals in common use that are present in electronics, furniture, clothing, toys, building materials, cleaning and personal care products, and most household items. It was enacted in 1976, and – in spite of the introduction of thousands of new chemicals, as well as the major progress made in the understanding of chemicals’ environmental and health impacts – it hasn’t been updated since then.

Attempts are being made to reform the TSCA, to modernise it and to update it.

The Guardian has a useful article aimed at providing a laypersons summary, here.

A more in depth summary of the legal developments is collated and published by the American Bar Association, here.