Dangerous Substances

Major accidents involving dangerous chemicals

Directive 2012/18/EU on the control of major-accident hazards involving dangerous substances

It aims to control major accident hazards involving dangerous substances, especially chemicals.

This Directive, so-called Seveso-III, amended the previous Seveso-II (Directive 96/82/EC), which, in view of the lessons learned from later accidents such as Bhopal, Toulouse or Enschede, had amended the original Seveso-Directive (Directive 82/501/EEC), after the catastrophic accident in the Italian town of Seveso in 1976 prompted the adoption of legislation on the prevention and control of such accidents.

KEY POINTS

This legislation has been changed to give the public stronger rights. It provides them with better access to information about the risks which might occur from nearby industrial installations and how to react in the event of an accident.

That information, which explains how alerts will be sounded and how the public should act, must be available online.

What has changed?

The law now covers some 12,000 industrial sites across the EU where chemicals or petrochemicals are used or stored, or where metal refining takes place.

Every EU country must ensure measures are in place to deal with accidents in areas around industrial installations housing large quantities of dangerous products:

Companies handling these substances above certain thresholds must:

regularly inform the people who could be affected by an accident
provide safety reports
establish a safety management system
put in place an internal emergency plan.

The new law also:

tightens the procedures for public consultation on projects, plans and programmes involving plants covered by the legislation.
ensures, through changes to land-use planning laws, that new plants are sited a safe distance away from existing ones.
allows people to go to court if they consider they have not been properly informed or involved.
introduces stricter inspection standards for the various installations, to ensure the safety rules are being effectively implemented.

Why the update?

The latest legislation takes account of certain technical European and international changes in the way chemicals are classified.

Background

Considering the very high rate of industrialisation in the EU, the Seveso Directive has contributed to achieving a low frequency of major accidents. The Directive is widely considered as a benchmark for industrial accident policy and has been a role model for legislation in many countries worldwide.

It has applied since 13 August 2012. EU countries must apply the new rules from 1 June 2015.

DOCUMENTS

Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC (OJ L 197, 24.7.2012, pp. 1-37)

Report from the Commission on the application in the Member States of Directive 96/82/EC on the control of major-accident hazards involving dangerous substances for the period 2012-2014 (COM(2017) 665 final of 16 November 2017)

Hazardous chemicals — rules on import and export

Regulation (EU) No 649/2012 — export and import of hazardous chemicals

It implements in the EU the Rotterdam Convention on import and export procedures for hazardous chemicals.
It ensures that countries receiving certain chemicals from the EU are:
informed about the export;
asked whether they agree to the export;
informed about the safe handling of chemicals to protect human health and the environment from potential harm.

Scope

The regulation applies to:
hazardous chemicals listed under the Rotterdam Convention;
chemicals that are banned or severely restricted within the EU;
chemicals that are exported.

It does not cover:
narcotics;
radioactive materials;
waste;
chemical weapons;
food and food additives;
feed;
genetically-modified organisms and some medicines; and
chemicals exported for research or analysis in quantities unlikely to affect human health or the environment.

The regulation requires proper labelling and packaging of chemicals when they are exported from an EU country.
186 chemicals (pesticides and industrial chemicals) are listed in Annex I and are subject to certain obligations when exported. Hazardous chemicals can either be exported on their own or blended into a mixture or article.

This regulation replaces Regulation (EC) No 689/2008 and updates some procedures and terminology that needed to be brought into line with other EU rules. In addition, it involves the European Chemicals Agency in implementing the legal requirements.

How it works

The regulation implements the two main procedures of the Convention, i.e. the Prior Informed Consent Procedure (PIC) and Information Exchange. It includes export notification in order to inform countries on the trade in certain chemicals, but it also goes further than the Convention, for example, by applying the procedures to exports to all countries, irrespective of whether they are parties to the Convention.

The PIC allows importing parties to the Convention to inform exporting parties on whether they agree to imports of the hazardous chemicals listed in the Convention. The regulation requires the explicit consent of the importing country for more chemicals than those listed in the Convention.
Each chemical listed in the Convention has a decision guidance document to help governments make a more informed decision. All parties are required to take a decision on allowing imports — known as an import response — and the regulation ensures that import responses are respected for EU exports.
Under the Information Exchange mechanism, each party must notify the Convention’s Secretariat when banning a chemical, and must notify the importing parties upon the export of such chemical. The regulation establishes the export notification procedure for EU exports of such chemicals to all importing countries.

All chemicals when exported must be labelled and packed according to certain standards and accompanied by basic safety information on a safety data sheet.
Each EU country must set up a designated national authority to be responsible for implementing the regulation.

The European Commission and EU countries share responsibility within the Convention, in particular in regard to:
technical assistance;
information-sharing; and
matters relating to dispute settlement.

DOCUMENT

Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (recast) (OJ L 201, 27.7.2012, pp. 60-106)

Successive amendments to Regulation (EU) No 649/2012 have been incorporated into the original document. This consolidated version is of documentary value only.The Regulation (EU) No 649/2012 is the recast version of Regulation (EC) No 689/2008 and its subsequent amendments. It has applied since 1 March 2014.

Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals (OJ L 204, 31.7.2008, pp. 1-35)

Council Decision 2006/730/EC of 25 September 2006 on the conclusion, on behalf of the European Community, of the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade (OJ L 299, 28.10.2006, p. 23-25)

Restriction on the use of certain hazardous substances in electrical and electronic equipment

Directive 2011/65/EU — restriction of the use of certain hazardous substances in electrical and electronic equipment

It strengthens existing rules on the use of hazardous substances, such as lead, mercury and cadmium, in electrical and electronic equipment (EEE) to protect human health and the environment, in particular by enabling environmentally sound recovery and waste treatment of EEE.

The recast legislation updates Directive 2002/95/EC which restricted the use of certain hazardous substances in EEE by, among other things, extending restrictions in the use of hazardous substances to a wider range of EEE.

Scope

An annex to the directive sets out the categories of EEE that are covered by the legislation. These range from household appliances to information technology (IT) equipment, plus an open catch-all category (relevant from July 2019).

The ban now applies to all EEE and to cables and spare parts. A short list of exclusions is given to certain special cases.
The ban was introduced gradually for certain products. It takes effect on:
22 July 2014 for monitoring and control instruments and medical devices;
22 July 2016 for in vitro medical devices;
22 July 2017 for industrial monitoring and control instruments; and
22 July 2019 for remaining product groups.

Exclusions

The restrictions do not apply to a range of items such as weapons, space equipment, large-scale stationary industrial tools (for example, printing presses, milling and drilling machines) and fixed installations (for example, electricity generators). Also exempt are photovoltaic panels.

Directive (EU) 2017/2102 amends Directive 2011/65/EU to address a number of issues, to avoid unintended consequences of the legislation because of the open scope introduced in 2011.

It excludes pipe organs and some non-road mobile machinery from its scope.

It also seeks to boost the circular economy by removing the ban on secondary market operations (which involve the repair, replacement of spare parts, refurbishment and reuse, and retrofitting) for EEE that fell outside the scope of the previous Directive 2002/95/EC, but which would not comply with Directive 2011/65/EU.

Reused spare parts, recovered from EEE, can be exempted provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of spare parts is notified to the consumer.

Exemptions

If specific criteria are met, the restrictions do not apply for a temporary period for certain exempted uses, such as the use of mercury in energy-saving light bulbs.
Two annexes list exemptions from the restrictions. Several exemptions have been added since the publication of the directive and others have expired and no longer apply; the exemption lists are continuously updated in line with technical progress.

Obligations

The directive places an obligation on manufacturers to ensure any EEE that they place on the market has been designed and produced in line with the requirements set out in the legislation.
Importers must check that equipment has been approved as meeting the required standards.
Distributors must also ensure the standards are met.

Adaptation and review

The various annexes, including the list of restricted substances and their tolerated concentration values, are reviewed regularly. They will be updated in line with scientific and technical progress and to take account of risks to human health and the environment.
The European Commission is to undertake a general review no later than 22 July 2021.

DOCUMENTS

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) (OJ L 174, 1.7.2011, pp. 88-110)

Successive amendments to Directive 2011/65/EU have been incorporated into the original document. This consolidated version is of documentary value only.

It has applied since 21 July 2011. Directive 2011/65/EU recast and replaced Directive 2002/95/EC (and its subsequent amendments) which had to become law in the EU countries by 2004. The new rules in Directive 2011/65/EU had to become law in the EU countries by 2013.

Use, storage and trade of mercury

Regulation (EU) 2017/852 — protecting human health and the environment from exposure to mercury and mercury compounds

It seeks to protect human health and the environment by laying down measures and conditions concerning:

the use and storage of and trade in mercury, mercury compounds and mixtures of mercury;
the production and use of and trade in mercury-added products (i.e. products to which mercury is intentionally added to perform the function for which the product is intended);
the management of mercury waste.

Trade, manufacture and storage of mercury

The regulation bans:

exports of mercury compounds and mixtures of mercury listed in Annex I as of 1 January 2018, depending on the compounds in question;
imports of mercury and mixtures of mercury from sources such as the chlor-alkali industry — other than for their disposal as waste;
the use of mercury and mercury compounds in manufacturing processes in which:
mercury or mercury compounds are used as catalysts* (since 1 January 2018)
mercury is used as an electrode* (as of 1 January 2022);
the export, import and production in the EU of mercury-added products from 31 December 2018 or 31 December 2020, depending on the product in question;
artisanal and small-scale gold mining and processing in which mercury amalgamation is used to extract gold from ore.

Dental amalgam

From 1 July 2018, mercury amalgam must no longer be used in fillings of milk teeth, the dental treatment of children under 15 and of breastfeeding or pregnant women.
EU countries must prepare a national plan on the measures they will use to phase out the use of dental amalgam.

Waste management

Waste facility operators may temporarily store mercury waste in liquid form if specific requirements for its storage are met and the storage is in a dedicated above-ground location that is appropriately equipped.
Temporary storage may not exceed 5 years (i.e. until 1 January 2023), although there is a possibility for an extension of 3 years.

Traceability

The regulation introduces a system to ensure traceability throughout the length of the mercury waste management chain. Waste producers and mercury waste facility operators must keep an information register.

Minamata Convention

The regulation enables the EU and EU countries to approve, ratify and implement the 2013 Minamata Convention on mercury signed by the EU and EU countries, and ensures that EU law is in line with the convention.

National law

EU countries may apply stricter requirements than those laid down in this regulation.

Review

The European Commission must report by 30 June 2020 on the outcome of the phasing out of dental amalgam. By 2024, it will prepare a report on the implementation and possible review of this regulation.

The regulation repeals Regulation (EC) No 1102/2008 with effect from 1 January 2018.

It has applied since 13 June 2017 except for point (d) of Part I of Annex III (relating to chlor-alkali production in which mercury is used as an electrode) which has applied since 11 December 2017.

DOCUMENTS

Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury, and repealing Regulation (EC) No 1102/2008 (OJ L 137, 24.5.2017, pp. 1-21)

Minamata Convention on Mercury

Decision (EU) 2017/939 concluding on behalf of the European Union the Minamata Convention on Mercury

It approves, on behalf of the EU, the Minamata Convention on Mercury — a global treaty that aims to protect human health and the environment from the adverse effects of mercury. The convention is included in the annex to the decision.

KEY POINTS

The Minamata Convention on Mercury — concluded under the auspices of the United Nations Environment Programme — sets up an international set of rules for cooperation and measures to limit the use of mercury and mercury compounds. It further aims to control and reduce anthropogenic emissions (i.e. relating to, or resulting from the influence of human beings) of mercury and mercury compounds to air, water and land.

The convention covers the complete life-cycle of mercury. It contains articles that introduce:

a ban on new mercury mines and a phase-out of existing ones;
restrictions on international trade in mercury;
control measures on emissions and releases;
measures to prohibit the manufacture, import or export of a range of mercury-added products;
measures to phase-out and phase-down the use of mercury in key manufacturing processes;
measures to phase down the use of dental amalgam;
measures to reduce mercury emissions from artisanal and small-scale gold mining and processing;
measures to ensure the environmental sound interim storage of mercury and mercury compounds and the environmental sound management of mercury waste.

The EU adopted Regulation (EU) 2017/852 to enable EU countries to implement the convention.It has applied since 11 May 2017.

BACKGROUND

Mercury is recognised as a substance producing significant adverse neurological and other health effects, with particular concerns expressed about its harmful effects on unborn children and infants. The global transport of mercury in the environment was a key reason for taking the decision that global action to address the problem of mercury pollution was required.

The EU signed the Minamata Convention on Mercury in October 2013 and thereby committed itself to ensuring its ratification and implementation.

DOCUMENTS

Council Decision (EU) 2017/939 of 11 May 2017 on the conclusion on behalf of the European Union of the Minamata Convention on Mercury (OJ L 142, 2.6.2017, pp. 4-39)

Council Decision (EU) 2017/938 of 23 September 2013 on the signing, on behalf of the European Union, of the Minamata Convention on Mercury (OJ L 142, 2.6.2017, pp. 2-3)

Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury, and repealing Regulation (EC) No 1102/2008 (OJ L 137, 24.5.2017, pp. 1-21)

Emissions of volatile organic compounds in paints, varnishes and vehicle refinishing products

Directive 2004/42/EC on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products

This directive, known as the ‘Paints Directive’ aims to limit the total content of volatile organic compounds (VOCs*) due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products. This would prevent or reduce air pollution resulting from the contribution of VOCs to forming ozone in the troposphere, the lowest layer of the earth’s atmosphere.

It has applied since 30 April 2004 and had to become law in the EU countries by 30 October 2005.

KEY POINTS

The directive defines the technical specifications for certain paints and varnishes (excluding aerosols) and vehicle refinishing products. They are principally coatings applied to buildings or vehicles. These products are listed in subcategories in Annex I of the directive.

This directive complements Regulation (EC) No 1272/2008 on the labelling of chemical substances and preparations and places the responsibility on EU countries to ensure that the products concerned are on sale only when they have a VOC content which does not exceed the limits set out in Annex II of the directive (ranging from 30 to 750 grams/litre (g/l) for paints and varnishes) and comply with the labelling requirements. The label must indicate:

the subcategory of the product and the relevant VOC limit values in g/l;
the maximum content of VOC in g/l of the product in a ready-to-use condition.

Annex II of the directive also lists maximum VOC content limit values for vehicle refinishing products. The European Commission will adapt this list to take account of technical progress.

EU countries must report the results of the monitoring programme to demonstrate compliance with the directive and the categories and quantities of products licensed. It must be reported to the Commission every 5 years. Countries must permit the free circulation of these products which, in their ready-for-use condition, comply with the directive’s requirements. They must also set penalties for infringing national rules adopted in line with the directive and make sure they are enforced.

The Commission submitted this report to the European Parliament and the Council, examining:

the broad potential to make reductions in the VOC content of products outside the directive’s scope, including aerosols for paints and varnishes;
the possible introduction, in a second phase, of a further reduction in the VOC content of vehicle refinishing products;
any new aspect of the socioeconomic impact of the second phase as envisioned for paints and varnishes.

The Commission also submitted a report taking account of technological developments in the manufacture of paints, varnishes and vehicle refinishing products. This report examines the broad scope and potential for making further reductions in VOC content of products within the scope of the directive, including the possible distinction between paints used for interiors and exteriors.

The Paints Directive amended the previous VOC Solvent Emissions Directive (Directive 1999/13/EC which has since been repealed by 2010/75/EU, the Industrial Emissions Directive) removing the sub-activity of ‘Vehicle Refinishing’ (the painting of road vehicles carried out as part of vehicle repair, conservation or decoration away from manufacturing installations) from its scope. This activity now comes under the scope of the Paints Directive.

As an exception (‘derogation’), such compliance is not required for paints, varnishes and vehicle refinishing products to be used:

for activities listed in Annex VII (Part I) to Directive 2010/75/EU and regulated in accordance with its Chapter V, or
for the restoration and maintenance of buildings and vintage vehicles of historical and cultural value.
The monitoring and reporting requirements are, from 16 July 2021, repealed and replaced by Regulation (EU) 2019/1020 on a national market surveillance strategy.

BACKGROUND

Volatile organic compound (VOC): any organic compound with high vapour pressure at ordinary room temperature, and a boiling point below 250°C, causing large numbers of molecules to evaporate and enter the surrounding air.

DOCUMENTS

Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC (OJ L 143, 30.4.2004, pp. 87-96)

Successive amendments to Directive 2004/42/EC have been incorporated into the original text. This consolidated version is of documentary value only.

Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, pp. 1-44)

Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ L 344, 17.12.2016, pp. 1-31)

Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (Recast) (OJ L 334, 17.12.2010, pp. 17-119)

Successive amendments to Directive 2010/75/EU have been incorporated into the original text. This consolidated version is of documentary value only.

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, pp. 1-1355)

Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national emission ceilings for certain atmospheric pollutants (OJ L 309, 27.11.2001, pp. 22-30)