Are chemical regulations being enforced?
Enforcement of Chemical Regulations in Finland in 2023–2025
Enforcement of Chemical Regulations in Finland in 2023–2025
All matter is made up of chemicals. Chemicals include substances and mixtures of substances. Some chemicals occur naturally and some are man-made. Some chemicals can be harmful to humans or the environment. The manufacture, import, distribution, use and storage of certain chemicals is strictly regulated. The authorities are responsible for ensuring that economic operators comply with the laws applicable to each product and process. The legal definition of economic operators covers not just manufacturers, importers, distributors and users of chemicals but also, for example, government bodies that buy chemicals for their own purposes or to distribute among the public.
Operators in Finland need to comply with both Finnish laws and EU-level chemical regulations. EU regulations are directly enforceable in Finland and binding on Finnish businesses. Finland can introduce national laws and regulations on the basis of EU directives or domestic priorities. As a rule, member states cannot introduce national laws that overlap with or contravene harmonised EU regulations. Laws are always enforced on a national level, which means that Finnish businesses are only subject to the oversight of Finnish supervisory authorities. The authorities’ mandates are enshrined in law, and government agencies cannot overstep their lawfully granted powers.
The laws governing chemicals are diverse, and multiple different authorities contribute to their enforcement. There are hundreds of laws that regulate the manufacture, import, distribution and use of chemicals in different contexts, and only some of these are discussed in this strategy. This enforcement strategy describes the duties, priorities and mandates of the Finnish Safety and Chemicals Agency, occupational safety and health authorities, environmental protection authorities, the Finnish Defence Forces, Finnish Customs, the Finnish Food Authority and the Finnish Environment Institute in respect of the enforcement of chemical regulations. The strategy explains how the supervisory authorities enforce the regulations governing the manufacture, import, sale, marketing, storage and use of biocidal products, plant protection products, industrial and consumer chemicals, cosmetics and articles containing various controlled chemicals, such as electrical and electronic appliances, textiles, batteries and jewellery. The focus is on the enforcement of the Finnish Chemicals Act, the Finnish Plant Protection Products Act and the Finnish Act on Cosmetic Products. Product controls (such as controls on construction materials and toys) are only examined from the perspective of the Chemicals Act. The strategy does not address controls on, for example, chemical waste, medicines, fertilisers, food products, food contact materials, radioactive substances, narcotics and drug precursors, alcohol or the carriage of dangerous goods or the enforcement of the Finnish Act on the Safe Handling and Storage of Dangerous Chemicals and Explosives, the Finnish Environmental Protection Act or the Finnish Occupational Safety and Health Act. In practice, however, many supervisory authorities incorporate the enforcement of these regulations into the controls that they carry out in the context of this strategy.
The strategy is also designed to describe cooperation between the authorities in Finland, their communication and information policies and Finland’s priorities in the enforcement of chemical regulations.
The strategy was formulated under the auspices of Finland’s national network of authorities responsible for the enforcement of chemical regulations. The members of the network include the Finnish Safety and Chemicals Agency (which coordinates the network and convenes its meetings), the Finnish Ministry of Agriculture and Forestry, the Finnish Ministry of Social Affairs and Health, the Finnish Ministry of the Environment, the Divisions of Occupational Safety and Health of Regional State Administrative Agencies, the Finnish Defence Forces, the Finnish Environment Institute, Centres for Economic Development, Transport and the Environment, Finnish Customs and the Customs Laboratory.
Achieving the objectives of chemical regulations, reducing the risks resulting from chemicals, plant protection products and cosmetics and protecting human health and the environment hinge on effective and correctly targeted controls.
The culture of enforcement must be based on treating businesses fairly and impartially. The general principles are as follows:
a) The regulations should be effectively enforced, but in ways which minimise the burden of checking compliance for both businesses and enforcing authorities.
b) Comprehensive risk analysis that takes into account both the effect of non-compliance and the probability that non-compliance will occur should be used.
c) Enforcing authorities should respond proportionately and carry out their duties independently, impartially and without bias.
Businesses should also be helped and encouraged to understand and meet their obligations derived from the regulations more easily. This includes the provision of readily accessible advice and guidance.
Point b) above mentions comprehensive risk analysis that takes into account both the effect of non-compliance on the risk to human health and the environment and the probability that non-compliance will occur. The risk to human health and the environment depends on the probability of exposure, the scale of exposure (such as the number of exposed individuals, the size of the geographical area affected and the period of exposure) and the level of danger presented by the chemical in question. Chemicals with severe inherent hazard properties that are supplied for wide and divergent use therefore pose a higher risk than less dangerous chemicals at low levels of exposure. The probability that non-compliance will occur depends on, for example, the level of awareness and knowledge of the regulations among businesses and other operators, combined with their ambition to be in compliance and the economic implications of complying, the probability of being found in non-compliance and the possibility of adverse public reaction.
In an ideal world, the competent authorities would have a thorough understanding of the businesses that operate in Finland, their disposition and competence to abide by the law, their products and whether these products are safe and in compliance with the relevant regulations. This is difficult to achieve in practice, as the target group could be seen to potentially include almost all businesses that manufacture, import, sell or use chemicals as well as public bodies such as local governments and health care providers. Ensuring the correct targeting and choice of controls therefore calls for risk-based prioritisation and cooperation between the authorities. Some laws contain detailed provisions on the enforcement duties of the competent authorities. For example, section 168 of the Finnish Environmental Protection Act obligates central supervisory authorities and municipal environmental protection authorities to carry out regular inspections of all operations that are subject to an environmental permit or registration and to choose the operators to be inspected and the frequency of inspections on the basis of environmental risk assessments.
The authorities have a range of ways in which they can help or compel operators to comply with the law. The authorities’ powers are enshrined in law – either the Finnish Administrative Procedure Act (see below) or one of the laws specific to chemicals. The authorities’ powers are described in more detail in section 5.
The procedures (self-assessments, quality control systems, etc.) of the operators themselves (businesses and government bodies) play a big role in ensuring that they understand their obligations and know how to, and are willing to, comply with the applicable laws. The authorities can help by providing advice and guidance. The Finnish Safety and Chemicals Agency operates a statutory national chemical advisory service, which is designed to educate small and medium-sized businesses in particular about their obligations under chemical regulations (the REACH Regulation, the CLP Regulation and the Biocidal Products Regulation). The advisory service responds to enquiries by e-mail and telephone. The obligation of the authorities to provide advice relating to other laws than the REACH Regulation, the CLP Regulation and the Biocidal Products Regulation is based on section 8 of the Finnish Administrative Procedure Act.
The political objectives of chemical regulations are set out in the applicable laws, and these also determine the priorities of enforcement.
In addition to the laws specific to chemicals (see section 3), the powers of Finnish authorities are subject to the legal principles of administration provided for in section 6 of the Finnish Administrative Procedure Act, according to which “[a]n authority shall treat equally those to whom it is providing services in administrative matters and shall exercise its competence only for purposes that are acceptable under the law. The acts of an authority shall be impartial and proportionate to the objectives sought. These acts shall protect expectations that are legitimate under the legal order.”
The Administrative Procedure Act applies to all of Finland’s supervisory authorities. In addition to the provisions of the Administrative Procedure Act, the authorities also need to take into consideration a large body of case law concerning, for example, the handling of complaints and the correct response in circumstances that resemble those of previous cases. Conflicting interpretations of the laws have been settled by various courts.
There is always a proactive element in the enforcement of chemical regulations. This can mean, for example, targeting controls at specific sectors or running thematic enforcement campaigns. Reactive components of the enforcement process include, for example, following up on allegations of non-compliances communicated to the supervisory authorities by consumers, other authorities or other businesses.
The enforcement of chemical regulations in Finland is risk-based, which means that the authorities endeavour to focus their attention on non-compliances that pose the highest risks to human health or the environment. Creating a level playing field for operators is also important. Promoting the publicity of the enforcement process is a constant priority.
The risk-based approach is pursued, in particular, by planning controls on the basis the authorities’ priorities. This means focusing on operations or products that could, in the event of non-compliance, pose a serious risk to human health or the environment.
Reactive enforcement is also risk-based in terms of the authorities’ chosen response. The authorities can choose to take a lenient view of minor shortcomings and react more forcefully to allegations of non-compliances that affect a large number of people or a large area and constitute a serious breach of the law.
The authorities’ role in creating a level playing field involves identifying operators who are breaking the rules and intervening in non-compliances in order to prevent these so-called free riders from making financial or other gains from their unlawful practices. A level playing field also requires the authorities to react consistently to all non-compliances of the same kind. This is especially important when an operator is being penalised for engaging in unlawful practices that are also pursued by other businesses. Such operators sometimes call the authorities’ attention to these other businesses, in which case the authorities need to enforce the rules consistently and also penalise any other rule-breakers. Individual cases can therefore turn into more extensive enforcement campaigns with more and more similar cases coming to light in the course of the process.
The publicity of the enforcement process is important from many perspectives. Consumers and other businesses can avoid using unlawful products if information about them is communicated clearly and transparently. One source of information about products that have been withdrawn from the market is the Finnish Safety and Chemicals Agency’s public market surveillance register. The European Commission has a database called Safety Gate (formerly RAPEX), which it uses to post weekly notices about dangerous non-compliant products intercepted by the supervisory authorities of EU member states.
Businesses can also use information about the results of controls to improve their practices in general. However, such results can only be published in so far as the information is not classified under the Finnish Act on the Openness of Government Activities or other laws. The authorities cannot publish confidential information (such as medical records or business and trade secrets). Details about pending cases are also usually not public information.
In deciding on the publicity of information relating to enforcement, the authorities need to consult the applicable laws and weigh up considerations such as consumers’ right to information about the operations of public authorities, the fair and impartial treatment of economic operators and the contribution of publicity and transparency to the pursuit of better public health and environmental protection as well as a level playing field for operators.
This strategy focuses on the enforcement of the Finnish Chemicals Act (599/2013), the Finnish Act on Cosmetic Products (492/2013) and the Finnish Plant Protection Products Act (1563/2011). These acts provide for the enforcement of a total of eight EU regulations. EU regulations are directly enforceable in all EU and EEA countries. It is up to economic operators to keep up to date with legislative reforms and ensure that they satisfy their obligations under EU regulations.
Other laws related to chemicals are listed in Appendix 2. The potential need to incorporate other laws than the ones discussed below into the scope of the strategy will be revisited when the strategy is next reviewed.
The Finnish Chemicals Act (599/2013) sets out the duties that the authorities have in enforcing EU-level chemical regulations in Finland. The Chemicals Act also provides for businesses’ disclosure obligations and language requirements for disclosures, a national authorisation procedure for certain types of biocidal products during the transition period prescribed in the European Biocidal Products Regulation as well as a procedure for operators performing pest control to demonstrate their competence.
The REACH Regulation provides for the registration, evaluation and authorisation of chemicals, restrictions relating to chemicals and the exchange of information up and down the supply chain. The acronym REACH stands for Registration, Evaluation, Authorisation and restriction of CHemicals. More information about obligations arising from the REACH Regulation is available on the Finnish Safety and Chemicals Agency’s website (in Finnish).
The CLP Regulation establishes an EU-wide system of classification, labelling and packaging of chemical substances and mixtures on the basis of the risks they pose. The acronym CLP stands for Classification, Labelling, and Packaging of chemicals. More information (in Finnish).
The Biocidal Products Regulation provides for the authorisation and placing on the market of biocidal products and articles treated with biocidal products. Biocidal products include, for example, disinfectants for skin, surfaces and drinking water, pest control products, such as rodenticides and insecticides, preservatives and wood preservatives used in industrial processes and products, underwater hull paints as well as antifouling products used in vessels and aquaculture facilities. More information.
The Detergents Regulation covers substances and preparations containing soaps and/or other surfactants intended for washing and cleaning processes. These include, for example, substances and preparations intended for washing laundry, fabrics, dishes and other hard surfaces, preparations intended for rinsing or bleaching clothes, domestic all-purpose cleaners and preparations intended for cleaning machinery and means of transport. More information. (in Finnish).
The POP Regulation concerns toxic organic chemicals of global concern due to their potential for long-range transport, persistence in the environment and ability to bio-accumulate in ecosystems. Most of these so-called persistent organic pollutants, or POPs, are substances traditionally used in industrial chemicals, flame retardants and pesticides. Some of the unwanted by-products are released accidentally through processes such as combustion. For more information, see http://www.ymparisto.fi/pop (in Finnish) and https://tukes.fi/en/chemicals/persistent-organic-pollutants-pop-.
The Mercury Regulation prohibits the export, import, use, storage and/or manufacture of products containing mercury, mercury compounds or mixtures of mercury as well as certain mercury-added products and closes the door to future new uses of mercury in industrial processes and in products. The use of mercury in existing products is provided for in other EU regulations. More information.
Operators in Finland are also bound by a number of national decrees that have been issued or preserved under the Chemicals Act:
The Finnish Plant Protection Products Act transposes Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides into Finnish law. The Plant Protection Products Act obligates professional users of plant protection products to demonstrate, among other things, professional competence, regular testing of spraying equipment and the existence of a system designed for integrated pest management. The Act also provides for enforcement, coercive measures and penalties.
The European Plant Protection Products Regulation sets out EU-level rules for the authorisation and placing on the market of plant protection products. Plant protection products are preparations used for protecting plants or plant products against harmful organisms in agriculture, forestry and horticulture as well as in towns, cities and recreational environments such as golf courses. Only plant protection products authorised by the Finnish Safety and Chemicals Agency can be sold or used in Finland. The Finnish Safety and Chemicals Agency can also set conditions for the use of products. Plant protection products that can be sold and used in Finland are listed in the Finnish Safety and Chemicals Agency’s Plant Protection Product Register.
More EU-level rules are set out in Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products (“Official Controls Regulation”). Most of the rules concerning enforcement procedures entered into force on 14 December 2019 but some requirements, such as those relating to laboratories, only apply as of 29 April 2022. The adoption of the Official Controls Regulation may also make it necessary to revise national laws.
The Finnish Act on Cosmetic Products (492/2013) provides for the duties of the authorities, language requirements for information provided about cosmetic products as well as certain other labelling requirements. The Act on Cosmetic Products governs the enforcement of the EU Cosmetics Regulation.
The Cosmetics Regulation lays down rules for manufacturers, importers and distributors of cosmetic products. These rules relate to, for example, product labelling requirements, safety assessments and reporting information to the European Commission’s cosmetic products notification portal (CPNP). More information.
The EU Market Surveillance Regulation (EU) 2019/1020 provides for the enforcement of product requirements set out in more than 60 individual pieces of legislation. It sets out, for example, the duties of market surveillance authorities and procedures for their cooperation with each other. The Regulation emphasises the importance of also enforcing the laws in respect of products offered for sale online and of market surveillance authorities’ being able to carry out their duties independently, impartially and without bias. The Regulation obligates the authorities to perform appropriate checks on the characteristics of products on an adequate scale (by means of documentary checks and, where appropriate, physical and laboratory checks) and based on adequate samples, prioritising their resources and actions to ensure effective market surveillance. Most of the provisions of the Regulation are effective as of 16 July 2021. The transposition of the Regulation into Finnish law requires a comprehensive reform of national laws to align Finland’s legislation with EU-level procedures.
Responsibility for the general management, supervision and development of operations governed by the Finnish Chemicals Act as well as the coordination and oversight of the enforcement of the Act and provisions issued under the Act is shared between the Finnish Ministry of Social Affairs and Health in respect of the prevention of any health-related effects of chemicals as well as physical risks and hazards and the Finnish Ministry of the Environment in respect of the prevention of any environmental risks and hazards posed by chemicals.
The general management and supervision of the implementation of the Finnish Plant Protection Products Act and the European Plant Protection Products Regulation are responsibilities of the Finnish Ministry of Agriculture and Forestry.
The Ministry of Social Affairs and Health is responsible for the coordination, oversight, supervision and development of the enforcement of the Finnish Act on Cosmetic Products.
Provision of advice
All the authorities that have powers under the Finnish Chemicals Act have a legal obligation to provide advice on the obligations arising from the Act and other regulations issued under the Act as well as to respond to questions and enquiries (Finnish Administrative Procedure Act, section 8). The REACH Regulation, the CLP Regulation and the Biocidal Products Regulation also expressly compel member states to establish national helpdesks to provide advice to small and medium-sized businesses in particular on their responsibilities and obligations under these three Regulations. In Finland, the provision of advice on chemicals is the responsibility of the Finnish Safety and Chemicals Agency. Information about the Finnish Safety and Chemicals Agency’s chemical advisory service can be found online at https://tukes.fi/en/chemicals and https://tukes.fi/kemikaalineuvonta (in Finnish). The service is designed to help businesses to meet their obligations.
Granting of authorisations
Only biocidal products and plant protection products that have been authorised under EU regulations can be placed on the market and used in Finland. In Finland, such authorisations are granted by the Finnish Safety and Chemicals Agency. The Biocidal Products Regulation also provides for the possibility to have certain biocidal products authorised at EU level. The transition period for the adoption of the Biocidal Products Regulation has not yet ended, and there are still biocidal products that have not been made subject to the authorisation procedure. Businesses apply to have their biocidal products authorised through the ECHA’s Register for Biocidal Products (R4BP).
The authorisation procedure for plant protection products applies to all plant protection products, and products that have not been authorised by the Finnish Safety and Chemicals Agency cannot be imported or sold in Finland even for personal use. Plant protection products that can be sold and used in Finland are listed in the Finnish Safety and Chemicals Agency’s Plant Protection Product Register.
The REACH Regulation provides for a special authorisation procedure for the use of substances listed in Annex XIV of the Regulation. Authorisations for these substances are granted by the European Commission.
No authorisation is required for the sale and supply of cosmetic products and chemicals other than the ones discussed above, and responsibility for their safety generally lies with the supplier.
More information about advisory services and authorisation procedures is available on the website of the Finnish Safety and Chemicals Agency.
The Finnish Chemicals Act splits the responsibility for the enforcement of the aforementioned EU regulations between multiple authorities according to their statutory mandates. The division of responsibilities is designed to prevent overlaps between the authorities’ powers; if the enforcement of a particular aspect of the law has been mandated to one authority, no other authority has competence in that respect. The laws governing chemicals are complex, which is why the Finnish Chemicals Act designates the Finnish Safety and Chemicals Agency as the competent authority in respect of every aspect of enforcement that has not been expressly assigned to another authority.
Responsibility for the enforcement of the Finnish Plant Protection Products Act is split between fewer authorities, but there are also provisions in the Chemicals Act that apply to plant protection products (such as those concerning safety data sheets, chemical notifications and warning labels).
The following paragraphs describe the roles of the various authorities in respect of different kinds of operations. The mandates of the authorities involved in the enforcement process are enshrined in law.
Import
Finnish Customs
Finnish Customs is responsible for the enforcement of European chemical regulations in the context of the import, export and transit of chemicals and products containing chemicals and the Finnish Chemicals Act in the context of the import, export and transit of biocidal products. In respect of import, Finnish Customs’ mandate covers chemicals and articles treated with chemicals. Finnish Customs’ product safety controls on imports also cover compliance with the restrictions set out in Annex XVII of the REACH Regulation.
Finnish Customs’ enforcement procedures are based on customs legislation and the obligations imposed on the authorities in charge of external border controls in Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (“Accreditation and Market Surveillance Regulation”) as well as the Finnish Act on the Market Surveillance of Certain Products (1137/2016), unless otherwise provided for its role in other laws relating to chemicals. The new Market Surveillance Regulation (EU) 2019/2020 will ultimately replace the Accreditation and Market Surveillance Regulation in respect of external border controls.
Finnish Customs’ role with regard to cosmetic products is to enforce the Finnish Act on Cosmetic Products and the European Cosmetics Regulation in respect of cosmetics imported into the EU and the export ban provided for in section 12 of the Finnish Act on Cosmetic Products. Finnish Customs is also responsible for the enforcement of the EU Cosmetics Regulation in connection with unloading and storing cosmetic products imported to Finland from other EU member states.
Manufacture, distribution, sale and marketing
Finnish Safety and Chemicals Agency
The Finnish Safety and Chemicals Agency is responsible for the enforcement of the Finnish Chemicals Act and provisions issued under the Act, the REACH Regulation, the CLP Regulation, the Detergents Regulation and the Biocidal Products Regulation as well as the prohibitions and restrictions on the production and placing on the market of chemicals referred to in Articles 3 and 4 of the POP Regulation and Articles 5 and 8 of the Mercury Regulation. The Finnish Safety and Chemicals Agency is the competent enforcement authority unless otherwise specified in the Finnish Chemicals Act. In practice, the Finnish Safety and Chemicals Agency is responsible for all aspects of market surveillance in the context of chemicals. These duties are therefore entrusted to a single competent authority.
The Finnish Plant Protection Products Act puts the Finnish Safety and Chemicals Agency in charge of the enforcement of laws governing plant protection products and for the coordination of the enforcement of rules relating to manufacture, import, placing on the market and marketing as well as handling and storage by importers and distributors. The Finnish Safety and Chemicals Agency is also responsible for all other aspects of enforcement relating to plant protection products that have not been mandated to the Finnish Food Authority.
In respect of cosmetics, the Finnish Safety and Chemicals Agency enforces the rules relating to the manufacture, the placing on the market and the making available of cosmetic products.
In practice, the Finnish Safety and Chemicals Agency is responsible for ensuring that economic operators
The Finnish Safety and Chemicals Agency’s role in enforcing chemical regulations covers online marketplaces as well as importers, wholesalers, industrial operators and brick-and-mortar businesses. With the growing popularity of online shopping, more and more attention needs to be given to the control of online marketplaces in order to ensure a level playing field for all operators and to stop dangerous and unlawful products from entering Finland through online channels.
Finnish Environment Institute
The Finnish Environment Institute is responsible for ensuring that economic operators
Use and storage
Occupational safety and health authorities
Occupational safety and health authorities’ role in the enforcement of chemical regulations focuses on monitoring the conditions in which chemicals are used at workplaces. In practice, this means Regional State Administrative Agencies’ Divisions of Occupational Safety and Health carrying out controls to ensure that employers comply with chemical regulations in respect of all work that is governed by the Finnish Occupational Safety and Health Act. Occupational safety and health authorities carry out controls and inspections on the basis of the Finnish Act on Occupational Safety and Health Enforcement and Cooperation on Occupational Safety and Health at Workplaces (44/2006). The aim is to ensure that employers provide a safe work environment for their staff.
To this end, occupational safety and health authorities check that employers are following the rules on working conditions and looking after the safety and health of their staff at the workplace. In addition to carrying out controls, occupational safety and health authorities also provide advice, guidance and information.
From the perspective of chemical regulations, this includes checking that employers are meeting their responsibilities and obligations in respect of, for example, drawing up risk assessments relating to chemical agents and making the documentation available to their occupational health care provider for the purposes of workplace surveys.
Employers must keep copies of risk assessments and analyses concerning any hazards in the workplace, including risks associated with chemical agents. These assessments and analyses must be reviewed whenever circumstances change and kept up to date otherwise as well. Employers who lack the competence to assess and analyse the risks inherent in their staff’s work themselves are advised to outsource these tasks to an external expert, such as their occupational health care provider. Employers’ duty to consult with occupational health care professionals and commission workplace surveys is provided for in the Finnish Occupational Health Care Act.
The aim is for businesses and organisations to make the safety and health of their staff one of their guiding principles and to adopt a systematic, forward-looking approach to ensuring that the legal requirements relating to the safety and health of workers are satisfied. This approach is called safety management. It is the employer’s duty to systematically analyse and identify any risks and hazards posed to workers’ safety and health by their work and the work environment. It is also the employer’s duty to take any reasonable steps to eliminate such risks and hazards.
Employers have a legal obligation to minimise their staff’s exposure to any chemical agents that could jeopardise their safety and health so as to not compromise their safety, health or reproductive health.
The ways in which exposure can be minimised depend on the characteristics of each chemical agent. The first option to explore is whether any dangerous chemical agents or processes can be substituted. If this is not possible, exposure can be lowered by minimising emissions, for example, by means of isolation or ventilation or by providing workers with personal protective equipment or other means of protection. Protecting workers against toxins, hypoxia and other serious dangers, such as cancer, allergies and foetal and genetic abnormalities, is especially important.
Employers must keep an up-to-date list of all the chemicals that their staff work with at the workplace, including the brand names of the substances. The list must also specify whether a safety data sheet is available. In the absence of safety data sheets, it is the employer’s obligation to draw up instructions for the safe use of chemical agents. Labels on chemical containers and packaging must be clearly legible, the information provided in Finnish and/or Swedish and specific to the chemical in question.
If a risk assessment reveals that workers could be exposed to a particular risk of illness or injury at the workplace, it is the employer’s duty to ensure that only qualified and suitable individuals perform this kind of work. Unauthorised access to any high-risk areas must be prevented.
Each of the authorities involved in the enforcement of chemical regulations has its own area of expertise. Occupational safety and health authorities’ role is to make sure that chemicals are used safely and that employers are following the rules so as to protect their staff’s safety and health. Occupational safety and health authorities’ competence to carry out controls and enforce the rules is based on the Finnish Act on Occupational Safety and Health Enforcement and Cooperation on Occupational Safety and Health at Workplaces (44/2006). One of the current priorities is to reduce workers’ exposure to chemical agents by focusing controls on compliance with statutory limit values and workplaces where dangerous chemicals are used. Occupational safety and health authorities also play a role in enforcing the REACH Regulation pursuant to the Finnish Chemicals Act.
The Finnish Act on Occupational Safety and Health Enforcement and Cooperation on Occupational Safety and Health at Workplaces obligates occupational safety and health authorities to report any non-compliances or shortcomings that they spot in the course of controls, such as safety data sheets or chemical labels not complying with the rules, other clear violations of the law governing the placing on the market of chemicals or any handling of chemicals in a way that could pose a risk to the environment, to the competent authority. In the context of chemical regulations, the competent authority can be, for example, the Finnish Safety and Chemicals Agency or, if a non-compliance relates to the handling of an environmentally hazardous chemical, the regional Centre for Economic Development, Transport and the Environment.
Centres for Economic Development, Transport and the Environment and municipal environmental protection authorities
Centres for Economic Development, Transport and the Environment and municipal environmental protection authorities (“environmental protection authorities”) carry out controls on the way in which economic operators use and store chemicals (including the manufacture of chemicals) in order to prevent adverse effects on the environment. Environmental protection authorities are competent to enforce chemical regulations in respect of all operations that are subject to the provisions of the Finnish Environmental Protection Act, i.e. activities that cause or may cause environmental pollution.
The division of responsibilities between Centres for Economic Development, Transport and the Environment and municipal environmental protection authorities is provided for in section 189 of the Environmental Protection Act.
Section 11 of the Finnish Chemicals Act gives environmental protection authorities the power to enforce certain obligations that economic operators have under EU chemical regulations and the Finnish Chemicals Act. Environmental protection authorities’ role in enforcing the REACH Regulation relates to the safety of the conditions in which chemicals are used (Articles 14.6, 37.5 and 37.6), which in practice means ensuring compliance with the instructions given in safety data sheets. Environmental protection authorities also enforce the rules on the use of substances that require authorisation (Title VII of the REACH Regulation) and substances that are subject to restrictions (Article 67 of the REACH Regulation).
In practice, environmental protection authorities mostly enforce chemical regulations in connection with controls on permits issued under the Finnish Environmental Protection Act. These controls are designed to ensure that operators are complying with their environmental permits in respect of environmental risk assessments, safety requirements concerning harmful substances, efforts to limit emissions, and monitoring and reporting obligations. Environmental protection authorities also check whether operators are complying with the general obligations concerning chemicals arising from the Environmental Protection Act. These include the obligation to know and manage any environmental risks posed by chemicals (section 6 of the Environmental Protection Act), the obligation to be prepared for emergencies (section 15 of the Environmental Protection Act), the obligation to prevent pollution (section 14 of the Environmental Protection Act), special obligations pertaining to the use of chemicals and the obligation to choose the least harmful alternative (section 19 of the Environmental Protection Act). Environmental protection authorities also check compliance on the basis of operators’ statutory reports and in connection with any proposals to change their plans and the terms of their environmental permit. The Environmental Protection Act puts Centres for Economic Development, Transport and the Environment in charge of the enforcement of numerous other chemical regulations (Appendix 2).
Environmental protection authorities also enforce restrictions on the use of persistent organic pollutants under the POP Regulation (Articles 3 and 4), the Mercury Regulation and compliance with the terms and conditions of authorisations for the use of biocidal products.
Centres for Economic Development, Transport and the Environment carry out controls on the use, handling and storage of plant protection products, for example, on farms and in greenhouses. Coordination is the responsibility of the Finnish Food Authority. Centres for Economic Development, Transport and the Environment also enforce the rules on the aerial spraying of plant protection products under section 22 of the Finnish Plant Protection Products Act.
Finnish Defence Forces
The Finnish Defence Forces enforce the Finnish Chemicals Act and European chemical regulations in the context of military operations and training of the Finnish Defence Forces, in facilities of critical significance from the perspective of national defence and in connection with crisis management.
Controls in non-critical facilities are carried out by other supervisory authorities as provided for in the Chemicals Act.
Finnish Food Authority
The Finnish Food Authority contributes to ensuring the safe handling and storage of plant protection products by coordinating the controls carried out by Centres for Economic Development, Transport and the Environment. Centres for Economic Development, Transport and the Environment and the Finnish Food Authority also carry out controls relating to agricultural subsidies. The full amount of subsidies can only be granted to farmers who only use authorised plant protection products. Farmers who breach the rules on cross-compliance relating to plant protection products risk having their subsidies cut. The basic-level conditions for support under the agri-environment-climate scheme also include requirements relating to plant protection products, and support payments to farmers can be reduced if the minimum requirements are not satisfied. The Finnish Food Authority and the Finnish Safety and Chemicals Agency draw up a plan for the enforcement of the rules on the sale and use of plant protection products each year.
The law provides for the means in which the authorities can enforce businesses’ compliance with their legal obligations. The means available for the Finnish Safety and Chemicals Agency, the Finnish Environment Institute, Centres for Economic Development, Transport and the Environment and municipal environmental protection authorities to enforce the Finnish Chemicals Act are provided for in the Chemicals Act. Controls carried out by Finnish Customs are governed by customs legislation and the Accreditation and Market Surveillance Regulation (EU 765/2008) as well as the Finnish Act on the Market Surveillance of Certain Products (1137/2016) in so far as enforcement by Finnish Customs is not provided for in other laws. Occupational safety and health authorities carry out controls and inspections on the basis of the Finnish Act on Occupational Safety and Health Enforcement and Cooperation on Occupational Safety and Health at Workplaces (44/2006).
The law gives the authorities the right to carry out inspections, access information and exchange information with other supervisory authorities as well as to give legally enforceable orders to economic operators. Each supervisory authority chooses the means by which to exercise its legal powers. These means include, among others, the following:
Prohibitions and orders
The authorities can prohibit products that are found to be unsafe or that do not satisfy the relevant requirements and operations that do not comply with the applicable rules. The authorities can also order businesses to stop supplying such products or to rectify such non-compliances by modifying a product design or a process, or to take other steps, such as produce documentation required by law.
Withdrawal from the market
The Finnish Safety and Chemicals Agency can order products with significant safety defects or that otherwise fall seriously short of satisfying the relevant requirements to be withdrawn from the market.
This means ordering the supplier to
Product recalls
The Finnish Safety and Chemicals Agency can order products with serious safety defects that can pose a risk to human health, property or the environment to be recalled.
This means ordering the supplier not only to withdraw the product from the market but also to
The authorities can threaten to fine any operators who fail to comply with the aforementioned kinds of prohibitions and orders. These so-called conditional fines are not meant to be punitive but coercive. Such fines are only payable if the order that the fine is designed to reinforce is not complied with. The authorities can also reinforce orders by threatening to take the steps necessary to achieve compliance and bill the operator in question for the costs afterwards if the operator fails to take action at their own initiative.
Moreover, the authorities can ask the police to investigate any operators who are found guilty of failures that are punishable by law. The decision as to whether or not to notify the police of violations of the Finnish Chemicals Act and the Finnish Act on Cosmetic Products rests with the competent supervisory authorities. In respect of violations of the Finnish Plant Protection Products Act, however, the Finnish Safety and Chemicals Agency and the Finnish Food Authority must notify the police unless the violation is clearly of minor significance, considering all the circumstances of the case.
The general rule in the context of chemical regulations is for the authorities to urge operators to comply with their legal obligations voluntarily by providing advice and instructions. Legally enforceable and appealable orders are generally only given if
The Forum for Exchange of Information on Enforcement (“Forum”) of the European Chemicals Agency (ECHA) is a network of authorities responsible for the enforcement of the REACH Regulation, the CLP Regulation and the PIC Regulation in the EU, Norway, Iceland and Liechtenstein. The Forum also has a Biocidal Products Regulation Subgroup (BPRS) established in 2017, which oversees the exchange of information on the enforcement of the Biocidal Products Regulation. The Forum and the BPRS are responsible for coordinating and harmonising the enforcement of EU chemical regulations. Coordinating the exchange of information on the enforcement of the POP Regulation has also been added to the Forum’s duties. The Forum and its mandate were established under EU regulations.
Finland’s national representative and deputy representative as well as the Finnish member of the BRPS are all currently from the Finnish Safety and Chemicals Agency. Finnish supervisory authorities take part in the Forum’s coordinated enforcement projects according to their respective mandates. The Forum runs what are known as REACH-EN-FORCE (REF) projects to which all member states contribute in one way or another. The Forum also coordinates a range of pilot projects that are designed to promote EU-wide enforcement and share best practices. The Forum’s project reports are uploaded to the Forum’s website.
Finland benefits from the work of the Forum. The enforcement projects coordinated by the Forum help to improve the quality of enforcement across the EU and also the compliance of businesses. Each enforcement project is subject to common rules, which also govern the reporting of results in order to compile harmonised statistics on the outcomes of enforcement in different member states. The Forum also helps to resolve conflicts of interpretation of the sometimes complex provisions of the REACH Regulation, the CLP Regulation and the Biocidal Products Regulation. The ability of the supervisory authorities of different member states to interpret the regulations consistently is especially important from the perspective of operators.
On the other hand, participating in the Forum’s work is a drain on national resources, and Finnish authorities need to choose their priorities in this respect.
The European Commission has set up a special Working Group for promoting cooperation between the authorities responsible for enforcing the rules on plant protection products. The objective is to ensure the consistent application of the Plant Protection Products Regulation and to improve the quality of enforcement. The Working Group has, for example, agreed on quantitative targets for sampling in order to collect EU-wide statistics on compliance with the regulations specific to plant protection products. Finland’s representative in the Working Group is from the Finnish Safety and Chemicals Agency.
The European Commission coordinates a platform of European market surveillance authorities in cosmetics (PEMSAC), which convenes approximately twice a year. PEMSAC reviews legislative reforms concerning cosmetic products and the need for reforms and seeks to establish harmonised interpretations of the obligations arising from the EU Cosmetics Regulation. Finland’s representative is from the Finnish Safety and Chemicals Agency.
The European Commission hosts an internet-supported information and communication system for pan-European market surveillance known as ICSMS, which is used to compile information about controlled products within the EU and non-compliances identified by the supervisory authorities of different member states. The Finnish administrator of ICSMS is the Finnish Safety and Chemicals Agency, although the database has only been used to report information about chemicals since the beginning of 2019. The system also includes a protocol for transferring responsibility for individual cases between the market surveillance authorities of the member states.
Finland’s national chemical notification system, KemiDigi, went live at the beginning of 2019. Businesses that manufacture, import and handle dangerous chemicals have a legal duty to submit chemical notifications to several different authorities. Thanks to the deployment of KemiDigi, businesses that process and import dangerous chemicals can now enter information about their chemicals directly into the KemiDigi system, where the information can be accessed by all the authorities that need it. KemiDigi also acts as Finland’s national chemical database. The new system makes it easier for the authorities to access information about chemicals, and ensuring the performance and availability of the system is of paramount importance. There is also potential to gradually turn KemiDigi into a tool that enforcement authorities could use to exchange information with each other.
The Finnish Safety and Chemicals Agency currently uses the ECHA’s Interact Portal for accessing and sharing confidential information about controls.
The European Commission’s cosmetic products notification portal (CPNP) is used by Finnish Customs, the Finnish Safety and Chemicals Agency and Helsinki University Hospital’s Poison Information Centre. All cosmetic products sold in the EU must be registered into the CPNP before they can be placed on the market.
The Finnish Safety and Chemicals Agency coordinates Finland’s national network of authorities, which is designed to promote cooperation in the enforcement of the Finnish Chemicals Act and the Finnish Plant Protection Products Act. The members of the network share topical information about the enforcement of chemical regulations, controls and the results of controls. The members also run joint enforcement campaigns and cooperate with each other on individual cases and in reporting about enforcement at EU level. Furthermore, the network provides a way to keep the authorities informed of the work of the ECHA’s Forum for Exchange of Information on Enforcement and coordinates Finland’s participation in the Forum’s enforcement projects. The members of the network currently include the Finnish Safety and Chemicals Agency (which coordinates the network and convenes its meetings), the Finnish Ministry of Agriculture and Forestry, the Finnish Ministry of Social Affairs and Health, the Finnish Ministry of the Environment, the Divisions of Occupational Safety and Health of Regional State Administrative Agencies, the Finnish Defence Forces, the Finnish Environment Institute, Centres for Economic Development, Transport and the Environment, Finnish Customs and the Customs Laboratory. The Finnish Medicines Agency and the Finnish Food Authority are due to join the network in the near future.
The authorities can also use the network as a means of sharing confidential information with each other when necessary. Moreover, the authorities can delegate individual cases to each other through the network. For example, occupational safety and health authorities or environmental protection authorities can ask the Finnish Safety and Chemicals Agency to take over a case if their controls reveal non-compliances relating to the labelling of dangerous chemicals, the availability of safety data sheets or the sale of controlled chemicals. Notifications from other authorities should ideally be sent by e-mail to [email protected]. Businesses and consumers are advised to report potentially unlawful products to the Finnish Safety and Chemicals Agency using the forms available at Tukes.fi.
Issues relating to the use and storage of chemicals, risk management, emissions and enforcement are discussed at meetings of a task force called KEHYS consisting of environmental protection officers of Centres for Economic Development, Transport and the Environment, environmental permit authorities of Regional State Administrative Agencies and officials of the Finnish Ministry of the Environment approximately four times a year.
The Finnish Ministry of Social Affairs and Health coordinates Finland’s Advisory Committee on Chemicals, which is a cooperation body consisting of the authorities responsible for the enforcement of the Finnish Chemicals Act as well as representatives of all relevant industry, trade and employees’ unions, research centres and non-governmental organisations. Finland’s Advisory Committee on Chemicals also has three subcommittees that deal with issues relating to enforcement: the Subcommittee for Biocides, the Subcommittee for International Affairs and the Subcommittee for Products.
Finland’s National Programme on Hazardous Chemicals was drawn up in 2012 and revised in 2016 and 2017. It sets out Finland’s most important objectives in terms of the safety of chemicals and steps to be taken to achieve them. One of the original objectives was to draw up a National Communications Plan for Dangerous Chemicals. The 2018–2020 National Communications Plan for Dangerous Chemicals is designed, among other things, to
promote cooperation between the authorities and research centres responsible for chemical-related matters in respect of communications,
maximise the effectiveness of communications and share resources,
identify the most critical target groups on the basis of risk assessments and agree on key messages and the objectives of communications targeted at each group, and
identify topics of current interest and agree on the division of communication responsibilities between the authorities and research centres in these respects.
These objectives should also be pursued in the targeting of controls on compliance with chemical regulations. Tangible cooperation between the authorities in the implementation of Finland’s National Programme on Hazardous Chemicals needs to be promoted and priority given to high-risk operations in order to identify potential issues resulting from chemicals and to resolve the issues together.
The Finnish Safety and Chemicals Agency publishes information about the results of enforcement in its market surveillance register and, since the beginning of 2019, through the European Commission’s ICSMS database. The Finnish Safety and Chemicals Agency’s annual plans for the enforcement of chemical regulations are published on the Finnish Safety and Chemicals Agency’s website. The European Commission publishes information reported by enforcement authorities across the EU about unsafe consumer products on a weekly basis (Safety Gate).
Reports on the enforcement of the rules governing plant protection products are submitted to the European Commission once a year. Information about controls on plant protection products is also included in reports submitted pursuant to Finland’s multi-annual national control plan, which covers the entire food chain. More information (in Finnish).
Information about the enforcement of chemical regulations and the results of controls are also communicated through other channels, such as social media.
Cooperation between the authorities in respect of communications is extremely important. Previous joint information campaigns have been effective in warning the public about unsafe products and educating businesses about their legal obligations in the case of products that have ties to multiple different laws.
The ECHA’s Forum for Exchange of Information on Enforcement has published a five-year plan called the Forum Work Programme 2019–2023. The programme sets out the following priorities for EU-wide enforcement of chemical regulations between 2019 and 2023:
Pursuing these priorities leaves national authorities with a huge number of businesses and products in need of special attention. Finland has no choice but to whittle down the priorities on a national level.
Controls need to be targeted so as to maximise the impact of the available resources. Finland’s national policy is therefore to focus on the chemicals, articles and operations that pose the greatest risks.
Agreeing on and applying a risk-based approach is difficult when there is a substantial gap between what needs to be done and the resources available for doing it. The significance of risks and the need for the authorities to react to them also have to be reviewed as more scientific data become available. Targeting controls on the basis of risk is challenging but necessary.
As a rule, the risk associated with each chemical depends on the characteristics of the chemical in question and the extent to which people or the environment are exposed to the chemical. CMRs (carcinogenic, mutagenic and reprotoxic substances) and PBTs (persistent, bio-accumulative and toxic substances) are subject to multiple legal restrictions, and ensuring that these restrictions are complied with and that the substances are used safely can be seen as one example of risk-based enforcement. Acutely toxic substances, allergens and corrosive chemicals also pose a high risk if, for example, they are classified, labelled, packaged or used contrary to the legal requirements.
More cooperation is needed to identify high-risk operations.
The authorities responsible for enforcing chemical regulations in Finland are independent bodies that choose their own enforcement priorities and draw up their own annual plans. The authorities’ resources are relatively limited considering the amount of work there is to do. Moreover, some non-compliances pose a higher risk to human health, the environment or the level playing field than others. The national network of authorities responsible for the enforcement of chemical regulations is designed to share information about various kinds of enforcement campaigns and enforcement priorities. However, more attention should be given to the potential of planning and implementing projects together and increasing cooperation otherwise. Efficient cooperation between the authorities also makes it easier to control distance selling so as to prevent the sale of unsafe products and educate the public about the risks involved in buying unlawful products.
Finland’s National Programme on Hazardous Chemicals includes a list of recommendations that need to be taken into account in the choice of enforcement priorities. Objective 3.2 advocates improving cooperation between supervisory authorities in occupational safety and health and environmental protection, while targeting supervision based on risks to identify and solve chemicals-related problems in companies. Objective 2 comes with the following recommendations relating to exposure to chemicals:
One way to promote a risk-based approach and closer cooperation between enforcement authorities would be to establish a national risk management body. The body could also act as an advisory group on various aspects of risk assessment and analysis relating to chemicals. The body would consist of the enforcement authorities and experts from national research centres (the Finnish Institute for Health and Welfare, the Finnish Institute of Occupational Health and the Finnish Environment Institute). The body would convene a few times a year, and its meetings would be called by the Finnish Safety and Chemicals Agency. The body would act as a contact point for promoting cooperation and the exchange of information between the authorities and research centres.
The strategy was formulated under the auspices of Finland’s national network of authorities responsible for the enforcement of chemical regulations. Finnish authorities work well together and share information with each other effectively. Agreeing on common priorities is nevertheless a time-consuming and labour-intensive process. This strategy sets out the authorities’ shared view of the status quo: the division of responsibilities, the current priorities and means of enforcement, and procedures for communication and cooperation.
The strategy needs to be reviewed at regular intervals. Legislative reforms and changes introduced to EU regulations may also make it necessary to revise the strategy. The full deployment of the new KemiDigi database may create better opportunities for cooperation between the authorities. Establishing a national risk management body as proposed in this document could also make it considerably easier for the authorities to agree on common priorities.
2020 Chemical Control Programme of the Finnish Safety and Chemicals Agency (in Finnish)
Environmental Monitoring Guidelines of the Finnish Ministry of the Environment (in Finnish)
REACH Enforcement Handbook for Environmental Protection Authorities (in Finnish)
Enforcement Programmes of Centres for Economic Development, Transport and the Environment (in Finnish)
Products and waste
Finnish Act on Explosives Precursors (73/2021); enforced by the Police and the Finnish Safety and Chemicals Agency
Finnish Act on Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (387/2013) and Decree of the Finnish Ministry of the Environment (419/2013); enforced by the Finnish Safety and Chemicals Agency
Finnish Act on Precious Metal Products (1029/2000) and Finnish Government Decree on Precious Metal Products (1148/2000); enforced by the Finnish Safety and Chemicals Agency
Finnish Waste Act (646/2011); enforced by environmental protection authorities
Finnish Government Decree on Waste Incineration (151/2013); enforced by environmental protection authorities
Finnish Government Decree on Scrapped Vehicles and Restrictions on the Use of Dangerous Substances in Vehicles (123/2015); enforced by environmental protection authorities
Finnish Government Decree on Restrictions on the Use of PCBs and the Processing of PCB Waste (958/2016); enforced by environmental protection authorities
Finnish Government Decree on Packaging and Packaging Waste (518/2014); enforced by the Finnish Safety and Chemicals Agency and environmental protection authorities
Finnish Government Decree on Batteries (520/2014); enforced by the Finnish Safety and Chemicals Agency
Finnish Government Decree on Waste Electrical and Electronic Equipment (519/2014); enforced by the Finnish Safety and Chemicals Agency
Finnish Decree on Charcoal Lighter Fluids (947/1973); enforced by the Finnish Safety and Chemicals Agency
European Construction Products Regulation (EU) No 305/2011; enforced by the Finnish Safety and Chemicals Agency
Finnish Act on the Safety of Toys (1154/2011); enforced by the Finnish Safety and Chemicals Agency
Finnish Narcotics Act (373/2008); enforced by the Finnish Medicines Agency
European drug precursor regulations (EC) No 273/2004, (EC) No 111/2005, (EU) 2015/1011 and (EU) 2015/1013; information about narcotics control on the website of the Finnish Medicines Agency.
Industrial processing and storage of dangerous chemicals
Air pollution control
Water protection
Soil conservation
Others