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.

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

Exiting the EU (UK & EU)

Further developments yesterday and today are set out below :

(1) the UK will also exit the European Economic Area (EEA) – this involves Article 127 of the EEA Agreement – a White Paper is expected on this. This is in addition to exiting the EU and Euratom.

(2) the European Parliament issued a draft Motion for a Resolution on the negotiations with the United Kingdom – this document is here.

(3) the European Council issued draft Guidelines for the negotiations, these were issued to 27 Member States and will be finalised at the EU27 meeting on 29th April – these Guidelines are here (curtesy of the Irish state broadcaster RTE).

On foot of these further developments, Email Alerts to subscribers to Cardinal Environment Limited EHS Legislation Registers and Law Checklists will be sent on Monday.

Carcinogens & Mutagens (EU Law)

An amendment to European Directive 2004/37/EC (Carcinogens and Mutagens) is expected to be adopted in February 2017. This amendment will set exposure limits for a further 11 carcinogens in addition to those covered by the existing 2004 directive. These are: 

* respirable crystalline silica dust

* 1,2-Epoxypropane

* 1,3-Butadiene

* 2-Nitropropane

* acrylamide

* certain chromium (VI) compounds

* ethylene oxide

* o-toluidine

* refractory ceramic fibres

* Bromoethylene

* Hydrazine

The amendment will also revise the limits for vinyl chloride monomer and hardwood dusts in the light of more recent scientific data. 

There will be minimum requirements for eliminating and reducing all carcinogens and mutagens. In line with the existing 2004 Directive, Employers will have to identify and assess risks to workers who are associated with exposure to specific carcinogens (and mutagens), and prevent exposure where risks exist. 

Substitution by a non or less-hazardous process or chemical agent will be required where this is technically possible. 

Email Alerts will be sent out. The Amendment proposal is here