Who is responsible for the safety of a chemical product?

2.6.2016 9.54


Responsibility for the chemical products lies with economic operators who must ascertain their relevant statutory duties and obligations before placing a product on the market.

Products/articles placed on the market are not inspected or investigated beforehand, and the competent agency or authority does not issue any preliminary approvals or rulings, with the exception of biocidal and plant protection products. Hence, Tukes as a supervisory authority has no specific information on the chemicals present in any given individual product. Economic operators, i.e. the manufacturers, importers and distributors of products within the area of the European Union, have always the primary responsibility for ensuring that the product complies with the requirements laid down in chemicals legislation. The economic operators should ascertain their own legal duties and obligations well in advance before placing the product on the market.

 What requirements does chemicals legislation impose on articles?

All articles, such as furniture, clothing, bicycles or product packaging, are ultimately composed of chemicals – either organic chemicals or inorganic man-made synthesised chemicals. It has been deemed to be necessary to expand regulation of chemicals also to cover a number of SVHC substances in articles as well as substances intended to be released gradually from articles over the course of usage.

Even though regulation of chemicals is stringent and is progressing all the time, regulation is not yet fully comprehensive, and medical symptoms can also be caused by a product which meets all the requirements imposed by chemicals legislation. There is a great variation in the chemical tolerance of different individuals. Chemicals legislation does not prohibit using substances classified as sensitisers or irritants in articles. Substances whose use is subject to restrictions can also be used providing that concentration of such a substance present in articles does not exceed the maximum allowed limit value laid down for the relevant substance. Individuals previously sensitised to a given substance may, however, react to exposure to concentrations falling below the maximum allowed limit value. The use of odorants is permitted, and current legislation does not require, for example, itemising in the product data sheet or other markings by name the chemicals used as odorants in articles. In this context, product choices made by consumers, together with contacting the responsible economic operator directly, have a central role to play.

On the basis of environmental and health risk assessments of substances carried out by the competent authorities of Member States and ECHA, new SVHC substances are being included all the time in the so-called SVHC Candidate List. These substances of very high concern can, for example, be carcinogenic, mutagenic or toxic to reproduction, persistent, bio-accumulative and toxic, or substances damaging the hormone system. Producers and importers have to submit a notification to ECHA concerning any SVHC substance present in their articles in certain cases.

In order to facilitate the safe use of articles, suppliers of articles must also inform their professional user customers of any SVHC substance present in their relevant articles above a concentration of 0.1% weight by weight. This information must also be provided to consumers on request. This statutory duty to provide information takes effect immediately when a substance is included in the Candidate List. Suppliers are bound by a similar duty concerning articles treated with biocidal products (e.g. mould and mildew prevention or disinfection treatment), and in these cases the active biocidal substance used must be indicated in the product markings.

The chemicals legislation of the European Union also contains a long list of chemical substances whose use is restricted either on its own, in a mixture or in an article. This list, namely the REACH Regulation Annex XVII, is continuously being updated in line with increasing chemical knowledge and information. Several restrictions under the REACH Regulation apply to substances in articles.

In the cases where an article is intended to release a substance which is present in each individual producer's or importer's relevant articles in quantities totalling over one tonne per year, the substance must be registered with ECHA through submission of a registration dossier. The objective of registration is to collect information on the properties of the substance and to ensure its safe use. Further information is available on the Tukes website.

 What is the role of the authority in the supervision of chemical safety?

Tukes is tasked with the supervision of compliance with legislation governing chemicals, cosmetic products and articles. Finnish Customs supervises the import of products.

Chemicals legislation has been harmonised across the European Union, i.e. all Member States have enacted similar laws. In some Member States certain further national requirements have been laid down in legislation.

 How does Tukes supervise chemical safety?

Tukes supervises compliance of both chemicals (substance, mixture) and articles containing chemicals on the market. The remit of chemical products market surveillance is extensive in terms of legal provisions and fields of operation. By means of market surveillance, Tukes seeks to ensure compliance of economic operators with their statutory duties and obligations as well as compliance of all products placed on the market with the legal requirements concerning, for example, the registration of chemicals, the labelling and packaging of hazardous chemicals, and the restrictions on the use of chemicals, including the associated permit and authorisation procedures.

Market surveillance is targeted either on the chemical products and articles containing chemicals sold at retail stores or on the products in the storage facilities of the relevant producers, importers and/or distributors. Surveillance can also be focused on specific product categories, chemicals or economic operators on the market. Surveillance mainly covers Finnish producers and importers and, to some extent, also downstream operators in the supply chain, such as distributors and retailers selling the relevant products. Field operations are mostly random inspections, but in many cases they can also be based on planned supervision and control projects. Surveillance operations are also undertaken on the basis of reports on products submitted to Tukes.

All supervision and surveillance activities are based on legislation, and, as an authority tasked with chemicals supervision and surveillance, Tukes has no legal mandate to issue any order concerning products on the market which comply with all the statutory requirements. Similarly, Tukes cannot impose on economic operators requirements other than those laid down in legislation. Legislation, however, lays down the minimum requirements only, and it is not prohibited to place on the market safer and better products.

The long-term and combination effects of all chemicals are not yet known. The competent national authorities of the Member States also cooperate with one another and participate in the environmental and health risk assessments of chemical substances. Within a short timeframe the European Union banned first the use of dimethyl fumarate in consumer products and then the import of products containing the substance, applied as a biocide e.g. in furniture or shoes, due to incidences of allergic reactions after skin contact with such products were reported in several Member States.

What will Tukes do after receiving reports from consumers on potentially dangerous or non-compliant products?

All reports received from consumers on potentially dangerous or non-compliant products are recorded in the information system, which enables a subsequent follow-up of reports and, where necessary, closer scrutiny if several reports have been made on the same product or brand, for example.

Consumers are advised to contact the store that sold the product and inform them of the issue related to the product so that they can address the problem together with the customer and supplier and, where necessary, with the relevant authority.

Visual appearance or intensive odour in itself does not, however, indicate potential hazard or danger or what substances the product contains. The agency needs more specific information in order to determine whether the product complies with the requirements laid down in chemicals legislation, for example, whether a given substance present in the product exceeds the concentration limit value specified in chemicals legislation. Such information can be based on a testing project or inspection carried out by Tukes or another authority, in which the product has been analysed in a test laboratory. The requisite information can also be requested from the relevant economic operator.

Exchange of information between other surveillance authorities is vital. For example, through the Rapid Alert System of the European Commission (RAPEX) Tukes receives information on the dangerous products found on the market that have been identified as posing a serious risk to human health and the environment. The economic operator can also voluntarily notify that a given product has been identified, for example, in the quality assurance and control process to be non-compliant with the statutory requirements. Subsequent to the notification, the surveillance authority assesses whether the measures proposed by the economic operator are sufficient to remedy the identified non-compliance, and, where necessary, provides guidance on the implementation of further measures.

In the cases where, on the basis of risk assessment carried out, Tukes may see fit, the agency will contact the economic operator and commence investigating the matter together with the economic operator. The agency has a legal obligation to investigate the matter and has the right to access to all information necessary for the supervision of compliance with chemicals legislation notwithstanding any document secrecy provisions laid down by law. The economic operator has the right to be heard in the matter and to present any records, documents and other accounts that have a bearing on the resolution of the matter.

The administrative sanctions that the supervisory authority may impose on the economic operator in the event of non-compliance are set out in the Chemicals Act. If the economic operator does not comply with the provisions of the chemicals legislation, the supervisory authority in question may ban the economic operator from continuing operations or repeating procedures in violation of the provisions or it may order the economic operator to otherwise fulfil the obligations laid down by law. For the supervision of compliance with chemicals legislation, the supervisory authority may, for example, issue orders concerning a chemical or article containing a chemical with respect to banning them from being placed on the market or from being made available on the market, the return procedure comprising the entire supply chain or only the end-users, or notification of the hazard inflicted. The supervisory authority may enforce a ban or order issued under the Chemicals Act by issuing notice of a conditional fine, by informing the economic operator that the measure that has been left unperformed will be carried out at the cost of the negligent economic operator.

Tukes also actively monitors through the RAPEX system the weekly listings of non-compliant dangerous products found on the European Union market that have been identified as posing a serious risk to human health and the environment, and the further measures undertaken concerning such products.

 Will Tukes investigate potentially harmful/dangerous products on the market on the basis of individual reports made by consumers?

Tukes does not have adequate resources to investigate the chemical composition of a product on the basis of individual reports, unless investigation can be justified by an especially weighty reason based on risk assessment.

As part of the overall surveillance activities, Tukes can investigate the chemical concentrations present in products of a given product category. Even in this case, the agency must know beforehand the particular chemical whose presence in the product is to be searched for. Solely on the basis of the unpleasant odour of the product or the symptoms described in the report made by the consumer, it is impossible to determine what chemical or chemicals may be present in the product. In practice, analysing dozens or even hundreds of different chemicals in the product is not feasible in the context of regular supervision activities.

Symptoms can triggered by a numerous factors other than a chemical present in the article. Establishing the causal connection with any certainty may be challenging, because symptoms are not always unambiguous.

Texts: Marilla Lahtinen, Elina Vaahtovuo, Paula Kuusio

Relevant EU chemicals legislation: REACH Regulation (EC) No 1907/2006