Chemicals and pesticides
EU chemicals and pesticides legislation aims to protect human health and the environment, as well as to prevent barriers to trade. It consists of rules governing the marketing and use of particular categories of chemical products, a set of harmonised restrictions on the placing on the market and use of hazardous substances, and protocols for handling major accidents and exports of dangerous substances. The two most important achievements at EU level are the CLP Regulation (classification, labelling and packaging) and the REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals). Under the European Green Deal and particularly the ‘chemicals for sustainability’, ‘farm to fork’ and ‘biodiversity’ strategies, EU legislation on these issues is currently undergoing a revision process.
Legal basis
Articles 191 to 193 of the Treaty on the Functioning of the European Union (TFEU).
Objectives and achievements
A. Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
EU chemicals policy underwent a radical overhaul with the introduction in 2006 of Regulation (EC) No 1907/2006 (the REACH Regulation). The regulation entered into force on 1 June 2007, establishing a new legal framework to regulate the development and testing, production, placing on the market and use of chemicals and replacing around 40 previous legislative acts. REACH introduced a single system for all chemicals and transferred the burden of proof concerning the risk assessment of substances from public authorities to companies. In addition, it demanded that the most dangerous chemicals to be substituted by suitable alternatives.
The European Chemicals Agency (ECHA), established under this regulation and based in Helsinki, is responsible for managing the technical, scientific and administrative aspects of REACH, and for ensuring consistency in its application. By November 2010, industries had to register all substances produced or imported in quantities over 1 000 tonnes per year, highly toxic substances in quantities over 100 tn/y, and hazardous carcinogenic, mutagenic or reprotoxic substances (CMRs) in quantities over 1 tn/y. In June 2013, the registration obligation was extended to all substances produced or imported in quantities of 100-1 000 tn/y, and finally, in June 2018, to all substances in quantities of 1-100 tn/y.
In February 2013, the Commission published a review of the REACH Regulation in which it concluded that REACH did not require any changes to its enacting terms, even though progress could be made in reducing the financial and administrative burden on industries and finding alternative methods to animal testing. In 2017, the Commission conducted a second evaluation under the regulatory fitness and performance programme (REFIT), the results of which were published in COM(2018)0116. The evaluation concludes overall that REACH was effective, but opportunities for further improvement, simplification and burden reduction were identified, which could be achieved by delivering the actions outlined in the report. Those should be implemented in line with the renewed EU industrial policy strategy, the circular economy action plan and the 7th environment action programme.
The Commission published a new chemicals strategy for sustainability on 14 October 2020. It is part of the EU’s zero pollution ambition, which is a key commitment of the European Green Deal. The strategy includes a revision of the REACH Regulation, prohibiting the use of the most harmful chemicals in consumer products such as toys, childcare articles, cosmetics, detergents, food contact materials and textiles, unless proven to be essential for society, and ensuring that all chemicals are used more safely and sustainably.
On 20 January 2022, the Commission launched a public consultation on the REACH revision.
B. Classification, packaging and labelling
In order to enhance the level of protection of human health and the environment, the same criteria for identifying, and labels for describing, chemical hazards should be used throughout the EU and the world. Adopted in 2008, Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) was introduced to align the EU system to the UN Global Harmonised System (GHS). The earlier directives on dangerous substances and preparations were repealed in June 2015.
On 19 December 2022, the Commission proposed a revised regulation on classification, labelling and packaging of chemicals (CLP) focusing on hazard communication, online sales and poison centre notifications. A delegated act (Regulation (EU) 2023/707) defining hazard classes, including endocrine disruptors, was adopted on 31March 2023.
C. Export and import of dangerous substances
EU rules on the export and import of dangerous chemicals were defined in Regulation (EU) No 649/2012, which aimed to promote shared responsibility and cooperative efforts in the international movement of hazardous chemicals, and to implement the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for Certain Hazardous Chemicals and Pesticides in International Trade. The PIC procedure consists in sharing information on toxic chemicals and awaiting a country’s explicit agreement before exporting the product in question. On August 25, 2023, the Commission released Commission Delegated Regulation (EU) 2023/1656 amending Regulation (EU) No 649/2012, adding 35 additional hazardous chemicals to the EU’s PIC regulation.
D. Major accidents
Named after an Italian municipality which was contaminated by an accidental release of dioxin from a nearby industrial site in 1976, the Seveso Directive (82/501/EEC) aimed to prevent major accidents such as fires and explosions and to limit the consequences of those that do occur by requiring safety reports, emergency plans and the provision of information to the public. In 1996, the Seveso II Directive (96/82/EC) on the control of major accident hazards involving dangerous substances introduced new requirements relating to safety management systems, emergency planning and land-use planning, and strengthened provisions on inspections carried out by Member States. In the light of a number of serious industrial accidents (in Toulouse, France; Baia Mare, Romania; and Enschede, the Netherlands), and on the basis of studies on carcinogens and substances dangerous for the environment, the scope of the Seveso II Directive was extended by Directive 2003/105/EC. The Seveso III Directive 2012/18/EU was published in July 2012 after being approved by Parliament and the Council. It takes account of new UN-agreed international classifications of substances that allow better risk evaluation and handling of substances.
In September 2021, the Commission published a report on the implementation and efficient functioning of the Seveso III Directive. The report shows that between 2015 and 2018, the number of major industrial accidents in the EU stabilised at a low level: 25 per year for 12 000 establishments.
E. Sustainable use of pesticides
Substances used to suppress, eradicate and prevent organisms that are considered harmful are grouped under the term ‘pesticides’. The term includes both plant protection products (PPPs) used on plants in agriculture, horticulture, parks and gardens, and biocidal products used in other applications, for example, as a disinfectant or to protect materials. In 2009, a Pesticides Package was adopted, consisting of: Directive 2009/128/EC on the sustainable use of pesticides (SUD), aimed at reducing environmental and health risks while maintaining crop productivity and improving controls on the use and distribution of pesticides; Regulation (EC) No 1107/2009 on the placing on the market of PPPs; and Regulation (EC) No 1185/2009 concerning statistics on pesticides, which sets out rules for collecting information on the annual quantities of pesticides placed on the market and used in each Member State.
Directive 2009/128/EC required the Member States to adopt national action plans (NAPs) for the establishment of quantitative objectives, targets, measures and timetables in order to reduce the risks and impact of pesticide use for human health and the environment. Aerial crop spraying is banned as a general rule, and no spraying at all is allowed in close proximity to residential areas. The regulation dealing with the production and licensing of pesticides contains a positive list of approved ‘active substances’ (the chemical ingredients of pesticides), drawn up at EU level. Pesticides are then licensed at national level on the basis of this list.
A controversy has emerged since 2015 over the renewal of the approval of glyphosate, one of the active substances most commonly found in broad-spectrum herbicides in the world. The controversy started as a result of diverging assessments of its carcinogenicity: the International Agency for Research on Cancer, a branch of the World Health Organization, classified glyphosate as probably carcinogenic to humans, while the European Food Safety Authority (EFSA) found it unlikely to pose a carcinogenic hazard to humans. The ECHA later concluded that glyphosate did not classify as a carcinogen. Several national authorities outside the EU also came to the same conclusion. The Commission eventually renewed the approval of glyphosate for five years in December 2017 and on 19 September 2023, the Commission introduced a proposed regulation to extend the approval of glyphosate for another ten years.
An implementation report on the SUD of 25 May 2020 showed that although Member States have made progress in implementing the SUD, fewer than one in three have completed the review of their NAPs within the five-year legal deadline. Of those that have reviewed their NAPs, most have failed to address the weaknesses identified by the Commission in their initial NAPs.
Under the European Green Deal and particularly its farm to fork and biodiversity strategies, the Commission will take actions to reduce by 50% the use and risk of chemical pesticides, including the use of the more hazardous pesticides, by 2030. To this end, on 22 June 2022 the Commission adopted the proposal to revise the SUD and promote the greater use of alternative ways to protect harvests from pests and diseases.
F. Biocidal products
Biocidal products such as antibacterial disinfectants and insect sprays are essential for managing harmful organisms affecting human and animal health. Yet, they can pose risks to humans, animals, and the environment. Regulation (EU) No 528/2012 entered into force in 2013 in order to simplify the authorisation mechanisms and enhance the role of the ECHA in reviewing approval dossiers on the basis of stricter conditions. The legislation reflects what was established under the previous regime, with controls over the marketing and use of biocides aimed at managing the associated risks to the environment and to human and animal health. These substances are authorised only if they appear on a positive list, while a ban applies to the most toxic chemicals - especially those that are carcinogenic or harmful to fertility, or interfere with genes or hormones (endocrine disrupters). Pursuant to the mutual recognition principle, a substance authorised in one Member State may be used throughout the EU. Regulation (EC) No 1107/2009 sets out scientific criteria for the determination of endocrine-disrupting properties of biocidal products, as well as PPPs.
G. Persistent organic pollutants (POPs)
POPs are chemical substances that persist in the environment because of their resistance to different forms of degradation (chemical, biological, etc.). They bioaccumulate through the food chain and can provoke adverse effects on human health and the environment. This group of priority pollutants consists of pesticides (such as DDT), industrial chemicals (such as polychlorinated biphenyls or PCBs) and unintentional by-products of industrial processes (such as dioxins and furans). The EU has committed itself at international level to controlling the handling, exportation and importation of POPs, under the Aarhus POP Protocol to the Geneva Convention on long-range transboundary air pollution (in force since 2003) and the Stockholm Convention on POPs (in force since 2004). The EU made additional progress with Regulation (EC) No 850/2004, which complements earlier EU legislation on POPs and aligns it with the provisions of the international agreements.
The recast Regulation (EU) 2019/1021 incorporates all of the amendments and corrigenda to the POPs Regulation up to 25 June 2019. It provides, inter alia, for the flame retardant decaBDE to be added to Annexes I and IV. The ‘unintentional trace contaminant’ limit is set at 10 mg/kg in substances. Specific exemptions concerning the use of decaBDE have been introduced for aircraft, motor vehicles and electrical and electronic equipment, and have been extended to imports. In 2021, the Commission adopted the proposal to review Annexes IV and V of the POPs Regulation, aiming to address the negative consequences of the presence of certain POPs substances in waste and in material that could be recovered from it. As a consequence, better waste management should also minimise emissions of POPs to air, water and soil.
H. Asbestos
Asbestos is a mineral with a fibrous structure, which is dangerous when inhaled. It was widely used in the past for insulation and other purposes, owing to its resistance to fire and heat. Directive 1999/77/EC enforced a ban on the use of asbestos has been in place in the EU since 1 January 2005. Furthermore, the extraction, manufacturing and processing of asbestos products is prohibited under Directive 2003/18/EC, repealed by Directive 2009/148/EC, which also lays down removal programme strategies to be implemented by the Member States. On 28 September 2022, the Commission presented a comprehensive approach to better protect people and the environment from asbestos. The package includes a Communication on working towards an asbestos-free future and a proposal to amend the Asbestos at Work Directive.
I. Detergents
Detergents refer to any substance or preparation containing soaps and/or other surfactants intended for washing and cleaning processes. Regulation (EC) No 648/2004 harmonises the rules on the biodegradability of surfactants, the restrictions and bans on surfactants, the information that manufacturers must provide, and the labelling of detergent ingredients. It was subsequently amended in 2006 (Regulation (EC) No 907/2006), 2009 (Regulation (EC) No 551/2009) and 2012 (Regulation (EU) No 259/2012), in order to introduce new biodegradability tests to provide an enhanced level of protection for the aquatic environment. In addition, the scope of the tests has been extended to include all classes of surfactant, thereby including the 10% of surfactants that hitherto had not been covered by legislation. On 28 April 2023 the Commission submitted a proposal to repeal Regulation (EC) No 648/2004. As regards labelling, Regulation (EC) No 907/2006 also extends the rules to include fragrance ingredients that could cause allergies, requiring manufacturers to disclose a full list of ingredients to medical practitioners treating patients suffering from allergies. As of 30 June 2013, the use of phosphates in laundry detergents is banned and the content of other phosphorus-containing compounds is limited.
Role of the European Parliament
Parliament played a key role in the development of the REACH Regulation. It secured the insertion of certain provisions at first reading – notably, in the registration chapter, a targeted approach with regard to data requirements for existing substances produced at lower tonnages (1-10 tonnes), and the ‘one substance, one registration’ (OSOR) approach intended to minimise costs, introducing an opt-out under specific conditions. In order to limit animal testing as much as possible, Parliament secured a requirement for companies to share data from tests conducted on animals (in return for reasonable compensation), thereby avoiding the need to duplicate experiments. As regards the authorisation chapter, Parliament endorsed a stronger approach whereby all substances of very high concern may only be authorised if a suitable alternative or technology does not exist.
During the long discussion on the pesticides package in 2008, amendments by Parliament ensured the establishment of appropriately sized buffer zones for the protection of aquatic organisms, along with the introduction of protection measures for the most vulnerable groups, including the prohibition of the use of pesticides in public gardens, sports and recreation grounds, school grounds and playgrounds, and in the close vicinity of healthcare facilities. In early 2013, following the publication of a report by the EFSA on the damaging effects of certain neonicotinoid insecticides, Parliament called on the Commission to take determined action to preserve bee populations. In March 2013, Parliament adopted a resolution on asbestos related to occupational health threats and prospects for eliminating all existing asbestos.
Parliament’s decision of 6 February 2018 on setting up a special committee on the Union’s authorisation procedure for pesticides (PEST) is a response to concerns raised about the risk posed by the herbicide substance glyphosate. The herbicide had its marketing licence renewed by the Commission for five years in December 2017. The special committee assessed: a) the authorisation procedure for pesticides in the EU; b) potential failures in how substances are scientifically evaluated and approved; c) the role of the Commission in renewing the glyphosate licence; d) possible conflicts of interest in the approval procedure; and e) the role of the EU agencies, and whether they are adequately staffed and financed to enable them to fulfil their obligations.
On 16 January 2019, Parliament adopted the report from the PEST special committee, which concluded, inter alia, the following: the public should be granted access to studies used in the authorisation procedure; the EU’s framework should stimulate innovation and promote low-risk pesticides; scientific experts should review studies on the carcinogenicity of glyphosate; and data requirements for PPPs should include long-term toxicity.
On 10 July 2020, Parliament adopted a resolution outlining its priorities as regards the upcoming chemicals strategy for sustainability. Parliament asked, among other things, that the strategy be used to develop coherence and synergies between chemicals legislation, occupational safety and health, and related EU legislation, including specific and general product legislation, legislation on water, soil and air, legislation on sources of pollution, including industrial installations, and legislation on waste. It underlined that the strategy should be based on robust and up-to-date scientific evidence, taking account of the risks posed by endocrine disruptors, hazardous chemicals in imported products, and combination effects of different chemicals and very persistent chemicals.
For more information on this topic, please see the website of the Committee on the Environment, Public Health and Food Safety (ENVI).
Georgios Amanatidis / Maria-Mirela Curmei