Tag Archives: Chemical

EU action plan on chemical, biological, radiological and nuclear security

EU action plan on chemical, biological, radiological and nuclear security

Outline of the Community (European Union) legislation about EU action plan on chemical, biological, radiological and nuclear security


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Justice freedom and security > Fight against terrorism

EU action plan on chemical, biological, radiological and nuclear security

Document or Iniciative

Communication from the Commission to the European Parliament and the Council of 24 June 2009 on Strengthening Chemical, Biological, Radiological and Nuclear Security in the European Union – an EU CBRN Action Plan .


The risks posed by terrorist groups acquiring chemical, biological, radiological or nuclear (CBRN) materials require coordinated action based on an all-hazard approach to preventing and detecting such cases. In recent years, such measures have been taken at both national and European Union (EU) level.

Developments so far

The responsibility to respond to CBRN threats mainly lies with Member States, many of which are fairly well-equipped to coordinate actions nationally. For crises that have cross-border implications, EU level procedures and tools have been developed to support Member States. They consist of the Community Mechanism for Civil Protection and the Crisis Coordination Arrangements (CCA). In addition, the Health Security Committee and the European Centre for Disease prevention and Control (ECDC) provide support for tackling health-related risks.

At EU level, actions to counter CBRN threats were first initiated at the Ghent European Council in 2001. Subsequently, the “Programme to improve cooperation in the European Union for preventing and limiting the consequences of chemical, biological, radiological or nuclear terrorist threats” was adopted in 2002. This was followed by the EU Solidarity Programme on the consequences of terrorist threats and attacks adopted in 2004, which was incorporated into the Strategy and Action Plan on Combating Terrorism adopted in 2005. The instruments used in the EU external relations consist, in particular, of the EU Strategy against Proliferation of Weapons of Mass Destruction (EU WMD Strategy), as well as of the Instruments for Stability, Nuclear and Security Cooperation (INSC) and Pre-Accession (IPA).

EU CBRN action plan

In February 2008, the Commission set up a CBRN Task Force to work on CBRN policy. Its final report of January 2009 provides the basis for the EU CBRN action plan. The main goal of CBRN policy is to minimise the threat and damage to the public from CBRN incidents through the:

  • use of a risk-based approach to security;
  • effective protection of CBRN materials;
  • improved exchanges of security-related information between Member States;
  • further development of detection systems in the EU;
  • provision of the necessary tools to manage CBRN incidents.

To this end, a coherent and prioritised EU action plan that involves all relevant stakeholders is implemented. It identifies three main areas of work:

  • prevention, which as the focal point of activity should first involve the use of risk-assessment to prioritise high-risk CBRN materials, and then focus on the security and control of these materials and the related facilities;
  • detection, which is seen as an essential supplement to prevention, as well as necessary for response. Consequently, detection systems should be set up within Member States and at the external borders of the Union. At EU level, minimum CBRN detection standards will be developed, testing and certification schemes will be established, and the exchanges of good practices will be enhanced;
  • preparedness and response, for which the existing measures should be further developed, with particular attention given to emergency planning, information flows, modelling tools, and countermeasure and criminal investigation capacity.

These areas of work are supported by various horizontal measures.

The action plan will mainly be implemented under existing structures, such as the Community Civil Protection Mechanism and the Civil Protection Financial Instrument. An EU CBRN Resilience Programme will also be launched in order to pool the civil protection actions of the plan. A CBRN Advisory Group will be set up to enable the Commission and the CBRN Task Force to continue collaborating during implementation.

The implementation of the action plan will be financed from existing programmes, primarily from the specific programmes “Prevention, Preparedness and Consequence Management of Terrorism and other Security related risks” and “Prevention of and Fight against Crime”. Additional financing may also be received from the Civil Protection Financial Instrument, the Seventh Framework Programme for Research, Technological Development and Demonstration Activities and the EU Health Programme 2008-13. The implementation will be regularly monitored and followed up, with a review carried out on the action plan in 2013.

External relations

The EU WMD Strategy adopted in December 2003 is the main component of the EU external relations policy regarding CBRN. A later updating of the strategy resulted in “New lines for action by the European Union in combating the proliferation of weapons of mass destruction and their delivery systems”, adopted in December 2008. Support for third countries is given in particular through the Instrument of Stability. Furthermore, regional centres of CBRN excellence and an Expert Support Facility mechanism will be established with a view to tackling CBRN risks internationally. Standard counter-terrorism and WMD clauses are also used in agreements with third countries.

Regulatory framework for the management of chemicals , European Chemicals Agency

Regulatory framework for the management of chemicals , European Chemicals Agency

Outline of the Community (European Union) legislation about Regulatory framework for the management of chemicals , European Chemicals Agency


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Institutional affairs > The institutions bodies and agencies of the union

Regulatory framework for the management of chemicals (REACH), European Chemicals Agency

Document or Iniciative

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [See amending act(s)].


The European Union (EU) has established REACH, an integrated system for the registration, evaluation, authorisation and restriction of chemicals, together with a European Chemicals Agency. REACH requires firms which manufacture and import chemicals to evaluate the risks resulting from the use of those chemicals and to take the necessary steps to manage any identified risk. Industry has the burden of proving that chemicals produced and placed on the market are safe.

The purpose of the regulation is to ensure a high level of protection of human health and the environment, and to strengthen the competitiveness of the chemicals sector and promote innovation.


The scope of the Regulation covers all substances *, whether manufactured, imported, placed on the market, or used on their own or in mixtures.

The following are excluded from the scope of the Regulation:

  • radioactive substances (covered by Directive 96/29/Euratom);
  • substances under customs supervision which are in temporary storage, in free zones or free warehouses with a view to re-exportation or still in transit;
  • non-isolated intermediates *;
  • the transport of dangerous substances; and
  • waste.

The rules on registration, downstream users, evaluation and authorisation do not apply to substances used in medicinal products for human or veterinary use or in food or feedingstuffs (including additives) provided they fall within the scope of Community legislation on medicinal products or food.


Registration is the key component of the REACH system. It will be compulsory to register in a central database chemicals which are manufactured or imported in quantities of one tonne or more per annum. The database will be managed by the European Chemicals Agency. If a substance is not registered it cannot be produced or placed on the European market.

Registration will be compulsory from 1 June 2008, but there will be transitional arrangements until 1 June 2018 in some cases for certain substances which must be pre-registered.

Some groups of substances (listed in the Regulation) are, however, exempt from the obligation to register, for instance:

  • polymers (however monomers which make up polymers must still be registered);
  • some substances for which the estimated risk is negligible (water, glucose, etc.);
  • naturally occurring and chemically unaltered substances;
  • substances used in research and development, under certain conditions.

Registration requires the industry (manufacturers and importers) to provide information on the properties and uses of chemicals and the precautionary measures to be taken when using them (technical dossier). The data required are proportional to the production volume of and the risks presented by the substance concerned (for example, extensive toxicity tests for substances manufactured or imported in quantities of more than 1000 tonnes). An application to register a substance which is imported or manufactured in a quantity of 10 tonnes or more per year must include a detailed description of the risks associated with that substance and the different possible exposure scenarios and risk management measures (chemical safety report).

There are “lighter” requirements for isolated intermediates, provided they are manufactured in strictly controlled conditions and for isolated intermediates which are transported and used under strict control in quantities of less than 1 000 tonnes. In these cases, only the classification, risk management measures and information already available on the properties are required. If more than 1 000 tonnes of the substance are being transported, further information is required.

Likewise, there are special arrangements for the registration of substances present in articles: given the millions of articles that are placed on the market in the EU and the potential risk some of them represent to human health and the environment, certain substances incorporated into articles must be registered. Registration is compulsory when the substance in question is normally released when the article is used and is present in those articles in quantities totalling over one tonne per producer or importer per year. For substances that are not normally released but which are particularly hazardous and are contained in a minimum concentration of 0.1% and placed on the market in quantities of over one tonne per producer or importer per year, simple notification is required, on the basis of which the European Chemicals Agency may request a registration.

The European Chemicals Agency is responsible for managing the database, receiving registration dossiers and developing technical guides aimed at helping manufacturers, importers and the competent authorities in implementing these provisions. During the first eleven years of application of the REACH system, around 30 000 substances already on the market should be registered. It is thought that about 80% of all registered substances will not need any further action.

Data sharing

The Regulation lays down a number of rules on data sharing in order to reduce testing on vertebrate animals and to reduce costs to industry. Provision is made for relevant data to be shared between registrants in exchange for payment.

To the same end, the Regulation requires all registrants of the same substance to submit their applications for registration together except in cases where there are grounds for not doing so, to protect confidential information, in case of disagreement with other registrants, or where joint submission of an application for registration involves disproportionate costs.

Information at the centre of the supply chain

Safety data will be passed throughout the supply chain so that those using chemicals in their production process to manufacture other preparations or articles will be able to do so safely and responsibly, without endangering workers’ or consumers’ health and without putting the environment at risk. This requires information to be passed both up and down the supply chain, and between all actors in that supply chain.

The data transmitted concern, inter alia, identification, composition and properties of the substances, the measures to be taken for use and transport without risk, the measures to be taken in case of fire or accidental release, and toxicological and ecological information. Sensitive information of a commercial nature does not have to be transmitted.

Downstream users

Downstream users must consider the safety of substances, based primarily on information from their suppliers, and to take appropriate risk management measures. These provisions also allow authorities to have an overview of the uses of a substance as it moves through the supply chain and, if necessary, to request further information and take appropriate measures.


Evaluation makes it possible for the Agency to check that industry is fulfilling its obligations and avoiding tests on vertebrate animals when unnecessary. Two types of evaluation are provided for: dossier evaluation and substance evaluation.

Dossier evaluation is to be compulsory for any applications to carry out tests specified in Annexes IX and X to the Regulation (these are the most stringent tests, mostly involving the use of vertebrate animals). The aim is essentially to minimise the need for experiments of this kind. Dossier evaluation may also be carried out in order to check the conformity of a registration. The Agency is expected to carry out a thorough review of at least 5% of the dossiers filed.

Substances suspected of posing a risk to human health or the environment may also be evaluated by the competent authorities in the Member States in order to determine whether further information is required. The evaluation programme is developed by the Agency, in cooperation with the competent authorities.

If a substance is suspected of posing a risk to human health or the environment, the Agency will include this substance in a specific list and a designated Member State will carry out an evaluation in order to determine whether further information is required from the registrant.

Evaluation can lead to the following conclusions:

  • the substance must be subject to restriction or authorisation procedures;
  • the classification and labelling of the substance must be harmonised;
  • information must be supplied to the other authorities so that they can adopt appropriate measures. For example, if, while the substance is being evaluated, information on risk management measures become available and could have an impact on the conditions of use of that substance, the information should be transmitted to the authorities responsible for this legislation.


Substances of extremely high concern may be subject to authorisation by the Commission with regard to particular uses. The objective is to ensure that the risks linked with these substances are validly controlled and that these substances are gradually replaced by other appropriate substances or technologies where this is economically and technically viable.

The Agency publishes and regularly updates a list of substances (‘list of candidate substances’) identified as having characteristics of extremely high concern. These may include the following:

  • CMRs (carcinogens, mutagens and reproductive toxins);
  • PBTs (persistent, bioaccumulative and toxic substances);
  • vPvBs (very persistent and very bioaccumulative substances);
  • some substances of concern which have irreversible serious effects on humans and the environment, such as endocrine disruptors.

The inclusion of candidate substances on the list involves, under certain conditions, the requirement of information on the presence of this substance in the articles. After inclusion of this substance in Annexe XIV to the Regulation any placing on the market and use of such chemical substances is subject to authorisation. This is granted if the risks arising from the substance in question can be validly controlled. If they cannot and if no alternative exists, the Commission is to assess the level of risk and the socio-economic advantages of using the substance and decide whether to authorise it or not. Some substances, such as PBTs and vPvBs can be authorised only if the socio-economic advantages override the risks and there are no alternatives.

The burden of proof is placed on the applicant. All authorisations must be reviewed after a certain period of time, determined on a case-by-case basis.

Downstream users may use a substance for an authorised use provided they obtain the substance from a company to which an authorisation has been granted and keep within the conditions of that authorisation. However, such downstream users must inform the Agency so that the authorities are fully aware of how certain substances of extremely high concern are being used.


The restriction procedure provides a safety net, making it possible to manage the risks which are not adequately covered by other provisions of the REACH system. Proposed restrictions may relate to the conditions of manufacture, use(s) and/or placing on the market of a substance, or the possible prohibition of such activities, if necessary. They are suggested by Member States or by the Agency (at the Commission’s request) in the form of a structured dossier and decided on by the Commission.

European Chemicals Agency

The Regulation establishes a European Chemicals Agency, responsible for managing the technical, scientific and administrative aspects of REACH and ensuring consistency of decision-making at Community level.

The Agency is also to manage the registration process and play a key role in the evaluation process. It receives applications for authorisation and delivers opinions and issues recommendations in relation to the authorisation and restriction procedures.

The Agency’s headquarters are in Helsinki.


Non-confidential information on chemicals is to be available, for example to allow those exposed to chemicals to take decisions as to the acceptability of the associated risks. Some information is accessible free of charge on the Agency’s website, other information on request. However, the Agency may not disclose confidential company data.

Competent authorities

The Regulation requires there to be authorities in each of the Member States with the competence and resources necessary to carry out the tasks assigned to them. These authorities must cooperate with each other and with the Agency in the performance of their duties.


The previous system often proved itself to be incapable of identifying risks posed by many chemicals and was slow to act when risks were identified.

The REACH system is complemented by Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures. This Directive integrates the classification criteria and rules on labelling of the United Nations’ Globally Harmonized System (GHS) with Community legislation and includes the REACH provisions governing the inventory of classifications and labelling.

Key terms used in the act
  • Substance: a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
  • Intermediate: a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance. There are: non-isolated intermediates (an intermediate that during synthesis is not intentionally removed from the equipment in which the synthesis takes place), on-site isolated intermediates (an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site) and transported isolated intermediates (an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites).


Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1907/2006

1.8.2008 (Art. 135)
1.6.2009 (Title VIII and Annex XVII)

OJ L 136 of 29.5.2007

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1354/2007


OJ L 304 of 22.11.2007

Regulation (EC) No 1272/2008


OJ L 353 of 31.12.2008

The successive amendments and corrections to Regulation (EEC) No 1907/2006 have been incorporated into the original text.


Annex II – Requirements concerning the compilation of safety data sheets
Regulation (EU) No 453/2010 [Official Journal L 133 of 31.5.2010].

Annex IV – Exemptions to the registration requirement in compliance with Article 2, paragraph 7, point a)
Regulation (EC) No 987/2008 [Official Journal L 268 of 9.10.2008].

Annex V – Exemptions to the registration requirement in compliance with Article 2, paragraph 7, point b
Regulation (EC) No 987/2008 [Official Journal L 268 of 9.10.2008].

Annex VI – Information requirements
Regulation (EU) No 453/2010 [Official Journal L 133 of 31.5.2010].

Annex XI – General rules on changes to the standard testing system
Regulation (EC) No 134/2009 [Official Journal L 46 of 17.2.2009].

Annex XIV – List of substances subject to authorisation
Regulation (EU) No 143/2011 [Official Journal L 44 of 18.2.2011].

Annex XV – Dossiers
Regulation (EC) No 1272/2008 [Official Journal L 53 of 31.12.2008].

Annex XVII – Restrictions on the manufacture, placing on the market and use of certain dangerous substances and preparations and certain dangerous articles
Regulation (EC) No 1272/2008 [Official Journal L 53 of 31.12.2008];
Regulation (EC) No 552/2009 [Official Journal L 164 of 26.6.2009];
Regulation (EU) No 276/2010 [Official Journal L 86 of 1.4.2010].

Related Acts

Commission Regulation (EC) No 771/2008 of 1 August 2008 laying down the rules of organisation and procedure of the Board of Appeal of the European Chemicals Agency [Official Journal L 206 of 2.8.2008].

Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) [Official Journal L 142 of 31.5.2008].

Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) [Official Journal L 107 of 17.4.2008].

Commission Regulation (EC) No 1238/2007 of 23 October 2007 on laying down rules on the qualifications of the members of the Board of Appeal of the European Chemicals Agency [Official Journal L 280 of 24.10.2007].