Imports of certain dangerous chemicals into the European Union (EU) are banned or severely restricted and subject to control measures laid down in Regulation (EU) 649/2012 (CELEX 32012R0649), which implements the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade, with a view to protecting human health and the environment from potential harm and contributing to the environmentally sound use of such chemicals.

These control measures are based on a standardised system of exchange of information between exporting and importing countries which allows the latter to identify potential hazards and exclude chemicals they cannot manage safely.

Import procedures

There are two basic import procedures:

• Prior Informed Consent (PIC) procedure
• Notification procedure

Prior Informed Consent (PIC) procedure

Exports of certain pesticides and industrial chemicals that have been banned or severely restricted for health or environmental reasons can only take place with the explicit prior informed consent (PIC) of the importing country.

The importing country may decide whether it accepts future shipments or not, or if it consents to import these products only subject to specified conditions.

Notification procedure

Until the chemical becomes subject to the PIC procedure, the designated national authority (DNA) of the country that plans to export a chemical that is banned or severely restricted for use within its territory, must inform the designated national authority of the importing country that such export will take place (notification procedure) before the first shipment and annually thereafter.

The European Chemicals Agency (ECHA) is the common national designated authority for the EU for all the administrative functions of the Convention: it sends and receives the export notifications from third countries, it establishes EU import decisions and submits PIC notifications.

Product scope

In Annex I to the Regulation are listed:

• Products included in a category of the Rotterdam Convention (i.e. pesticides or industrial chemicals) or in one of the European Union's subcategories (i.e. pesticide used as a plant protection product, biocidal product, industrial chemical for use by professionals, industrial chemical for use by the public).
• Chemicals or chemical groups that are subject to the PIC procedure according to the Rotterdam Convention.

Legislation

• Regulation (EU) 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L-201 27/07/2012) (CELEX 32012R0649)
• Council Decision 2006/730/EC of 25 September 2006 on the conclusion, on behalf of the European Community, of the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade (OJ L-299 28/10/2006) (CELEX 32006D0730)
• Communication 2011/C 65/01 from the Commission Technical guidance notes for implementation of Regulation (EC) No 689/2008 Publication made in accordance with Article 23 of Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals (OJ C-65 01/03/2011) (CELEX 52011XC0301(04))
• Commission Implementing Decision (EU) 2016/770 of 14 April 2016 establishing a common format for the submission of information concerning the operation of the procedures pursuant to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (OJ L-127 18/05/2016) (CELEX 32016D0770)
• Commission Decision 2000/657/EC of 16 October 2000 adopting Community import decisions for certain chemicals pursuant to Council Regulation (EEC) No 2455/92 concerning the export and import of certain dangerous chemicals (OJ L-275 27/10/2000) (CELEX 32000D0657)
• Commission Decision 2001/852/EC of 19 November 2001 on adopting Community import decisions pursuant to Council Regulation (EEC) No 2455/92 concerning the export and import of certain dangerous chemicals and amending Decision 2000/657/EC (OJ L-275 27/10/2000) (CELEX 32001D0852)
• Commission Decision 2003/508/EC of 07 July 2003 adopting Community import decisions for certain chemicals pursuant to Regulation (EC) No 304/2003 of the European Parliament and of the Council and amending Decisions 2000/657/EC and 2001/852/EC (OJ L-174 12/07/2003) (CELEX 32003D0508)
• Commission Decision 2004/382/EC of 26 April 2004 adopting Community import decisions for certain chemicals pursuant to Regulation (EC) No 304/2003 of the European Parliament and of the Council (OJ L-144 30/04/2004) (CELEX 32004D0382)
• Commission Decision 2005/416/EC of 19 May 2005 adopting Community import decisions for certain chemicals pursuant to Regulation (EC) No 304/2003 of the European Parliament and of the Council and amending Decisions 2000/657/EC, 2001/852/EC and 2003/508/EC (OJ L-147 10/06/2005) (CELEX 32005D0416)
• Commission Decision 2005/814/EC of 18 November 2005 adopting Community import decisions for certain chemicals pursuant to Regulation (EC) No 304/2003 of the European Parliament and of the Council and amending Decision 2000/657/EC (OJ L-304 23/11/2005) (CELEX 32005D0814)
• Commission Decision 2009/875/EC of 30 November 2009 adopting Community import decisions for certain chemicals pursuant to Regulation (EC) No 689/2008 of the European Parliament and of the Council (OJ L-315 02/12/2009) (CELEX 32009D0875)
• Commission Decision 2009/966/EC of 30 November 2009 adopting Community import decisions for certain chemicals pursuant to Regulation (EC) No 689/2008 of the European Parliament and of the Council and amending Commission Decisions 2000/657/EC, 2001/852/EC, 2003/508/EC, 2004/382/EC and 2005/416/EC (OJ L-341 22/12/2009) (CELEX 32009D0966)
• Council Decision 2011/162/EU of 14 March 2011 establishing the position to be taken by the European Union within the fifth meeting of the Conference of the Parties of the Rotterdam Convention as regards the amendments to Annex III to the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade (OJ L-70 17/03/2011) (CELEX 32011D0162)
• Council Decision (EU) 2019/668 of 15 April 2019 on the position to be taken on behalf of the European Union at the ninth meeting of the Conference of the Parties as regards the listing of certain chemicals in Annex III to the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (OJ L-113 29/04/2019) (CELEX 32019D0668)
• Commission Implementing Decision 2012/C 177/05 of 15 June 2012 adopting Union import decisions for certain chemicals pursuant to Regulation (EC) No 689/2008 of the European Parliament and of the Council (OJ C-177 20/06/2012) (CELEX 32012D0620(01))
• Commission Implementing Decision 2016/C 61/06 of 11 February 2016 adopting Union import decisions for certain chemicals pursuant to Regulation (EU) No 649/2012 of the European Parliament and of the Council and amending Commission Decisions 2005/416/EC and 2009/966/EC (OJ C-61 17/02/2016) (CELEX 32016D0217(01))
• Commission Implementing Decision 2018/C 376/06 of 10 October 2018 laying down the final import response on behalf of the Union concerning the future import of certain chemicals pursuant to Regulation (EU) No 649/2012 of the European Parliament and of the Council and amending Commission Implementing Decision C(2016)747 (OJ C-376 18/10/2018) (CELEX 32018D1018(02))
• Council Decision (EU) 2015/423 of 6 March 2015 establishing the position to be adopted on behalf of the European Union within the seventh meeting of the Conference of the Parties to the Rotterdam Convention as regards the amendments of Annex III to the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade (OJ L-68 13/03/2015) (CELEX 32015D0423)
• Commission Implementing Decision (EU) 2016/1115 of 7 July 2016 establishing a format for the submission by the European Chemicals Agency of information concerning the operation of the procedures pursuant to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (OJ L-186 09/07/2016) (CELEX 32016D1115)

Other information sources

• Rotterdam Convention: http://www.pic.int/
• European Chemicals Agency (ECHA): https://www.echa.europa.eu/
• Chemicals subject to PIC: https://www.echa.europa.eu/information-on-chemicals/pic/chemicals
• Prior Informed Consent Regulation: https://www.echa.europa.eu/regulations/prior-informed-consent/understanding-pic
• ePIC - Prior Informed Consent IT system: https://www.echa.europa.eu/web/guest/support/dossier-submission-tools/epic
• Trade of Dangerous Chemicals: https://ec.europa.eu/environment/chemicals/trade_dangerous/index_en.htm
• Commission Expert Group on implementation of the Rotterdam Convention: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=483

Imports into the European Union (EU) of metallic mercury (Hg CAS RN 7439-97-6) and mixtures of mercury listed in Annex I and Annex II to Regulation (EU) 2017/852 (CELEX 32017R0852) are prohibited or severally restricted, in order to ensure a high level of protection of human health and of the environment.

These measures are aimed at ensuring the fulfilment of the obligations of United Nations Minamata Convention on Mercury.

The import of these products may be allowed, only if the importing Member State has granted written consent to such import in either of the following circumstances:

• the exporting country is a Party to Minamata Convention on Mercury and the exported mercury is not from primary mining that is prohibited under Article 3 (3) and (4) of the Convention; or
• the exporting country not being a Party to the Minamata Convention on Mercury has provided certification that the mercury is not from primary mercury mining; or
• the mercury or the mixtures are imported for disposal purposes as waste, where the exporting country has no access to available capacity within its own territory.

Legislation

• Regulation (EU) 2017/852 of the European Parliament and the Council of 17 May 2017 on mercury, and repealing Regulation (EC) No 1102/2008 (OJ L-137 24/05/2017) (CELEX 32017R0852)
• Commission Implementing Decision (EU) 2017/2287 of 8 December 2017 specifying the forms to be used in relation to the import of mercury and of certain mixtures of mercury pursuant to Regulation (EU) 2017/852 of the European Parliament and of the Council on mercury (OJ L-328 12/12/2017) (CELEX 32017D2287)
• Council Decision (EU) 2018/1730 of 12 November 2018 on the position to be taken on behalf of the European Union at the second meeting of the Conference of the Parties to the Minamata Convention on Mercury with regard to the adoption of guidelines on the environmentally sound interim storage of mercury, other than waste mercury, referred to in Article 10(2) and (3) of the Convention (OJ L-288 16/11/2018) (CELEX 32018D1730)
• Council Decision (EU) 2019/2135 of 21 November 2019 on the position to be taken, on behalf of the European Union, at the third meeting of the Conference of the Parties to the Minamata Convention on Mercury, as regards the adoption of a Decision on the phasing-out of dental amalgam and amending Annex A to that Convention (OJ L-324 13/12/2019) (CELEX 32019D2135)
• Council Decision (EU) 2019/2119 of 21 November 2019 on the position to be taken, on behalf of the European Union, at the third meeting of the Conference of the Parties to the Minamata Convention on Mercury, as regards the adoption of a Decision establishing thresholds for mercury waste, as referred to in Article 11(2) of that Convention (OJ L-320 11/12/2019) (CELEX 32019D2119)
• Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)

Other information sources

• Minamata Convention on Mercury: https://www.mercuryconvention.org/
• Mercury overview: https://ec.europa.eu/environment/chemicals/mercury/index_en.htm
• Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en
• Group of Experts on Mercury: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=3535

Imports of persistent organic pollutants (POPs) into the European Union (EU) are prohibited or severally restricted, so as to eliminate or minimise the use of these products to protect human health and the environment.

These measures implement the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.

Persistent organic pollutants are toxic chemical substances which resist degradation. They remain in the environment for decades, become widely distributed geographically and accumulate in living organisms, where they can damage human health and wildlife. This group of pollutants consists of pesticides (such as DDT), industrial chemicals (such as polychlorinated biphenyls - PCBs) and unintentional by-products of combustion and industrial processes (such as dioxins and furans).

Regulation (EU) 2019/1021 (CELEX 32019R1021) lays down the prohibition on imports of intentionally produced POP substances listed in its Annex I, whether on their own, in preparations or as constituents of articles.

POPs may only be imported under certain circumstances, if an exemption has been granted authorising production and use of the substances in question, e.g. for environmentally sound disposal of existing POPs (destruction of waste, etc.) or for laboratory scale-research.

These restrictions are in line with those laid down by Regulation (EC) 1907/2006 (CELEX 32006R1907) which can be imposed on the use of a substance in certain circumstances and products, on the use by consumers or even on all uses (complete ban of a substance).

According to this Regulation, any substance on its own, in a preparation or in an article, may be subject to restrictions if its use poses unacceptable risks to health or the environment. Restrictions apply to all manufacturers, importers, downstream users and distributors of a substance if the manufacture, use or placing on the market of this substance is listed in Annex XVII.

Legislation

• Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L-169 25/06/2019) (CELEX 32019R1021)
• Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) 793/93 and Commission Regulation (EC) 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L-396 30/12/2006) (CELEX 32006R1907)
• Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)
• Council Decision 2004/259/EC of 19 February 2004 concerning the conclusion, on behalf of the European Community, of the Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants (OJ L-81 19/03/2004) (CELEX 32004D0259)
• Council Decision (EU) 2016/769 of 21 April 2016 on the acceptance of the Amendments to the 1998 Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants (OJ L-127 18/05/2016) (CELEX 32016D0769)
• Council Decision (EU) 2016/768 of 21 April 2016 on the acceptance of the Amendments to the 1998 Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Heavy Metals (OJ L-127 18/05/2016) (CELEX 32016D0768)
• Council Decision 2006/507/EC of 14 October 2004 concerning the conclusion, on behalf of the European Community, of the Stockholm Convention on Persistent Organic Pollutants (OJ L-209 31/07/2006) (CELEX 32006D0507)
• Commission Decision 2009/63/EC of 20 November 2008 defining a format for the submission of the information by Member States in accordance with Article 7(4)(b)(iii) of the Regulation (EC) No 850/2004 of the European Parliament and of the Council (OJ L-23 27/01/2009) (CELEX 32009D0063)
• Council Decision (EU) 2015/627 of 20 April 2015 on the position to be taken, on behalf of the European Union, at the seventh meeting of the Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants as regards the proposals for amendments to Annexes A, B and C (OJ L-103 22/04/2015) (CELEX 32015D0627)
• Council Decision (EU) 2019/448 of 18 March 2019 on the submission, on behalf of the European Union, of a proposal for the listing of methoxychlor in Annex A to the Stockholm Convention on Persistent Organic Pollutants (OJ L-77 20/03/2019) (CELEX 32019D0448)
• Council Decision (EU) 2019/639 of 15 April 2019 on the position to be taken on behalf of the European Union at the ninth meeting of the Conference of the Parties as regards amendments to Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants (OJ L-109 24/04/2019) (CELEX 32019D0639)
• Council Decision (EU) 2021/592 of 7 April 2021 on the submission, on behalf of the European Union, of a proposal for the listing of chlorpyrifos in Annex A to the Stockholm Convention on Persistent Organic Pollutants (OJ C-125 13/04/2021) (CELEX 32021D0592)

Other information sources

• Stockholm Convention on Persistent Organic Pollutants: http://www.pops.int/
• Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution: https://unece.org/environment-policyair/protocol-persistent-organic-pollutants-pops
• Persistant Organic Pollutants (POPs): https://ec.europa.eu/environment/chemicals/international_conventions/index_en.htm
• General information about REACH: https://ec.europa.eu/environment/chemicals/reach/reach_en.htm
• Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en
• Commission Expert Group on Persistent Organic Pollutants: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=1656

The placing on the European Union (EU) market of fertilising products and other products relevant as inputs for agriculture, such as soil improvers and growing media, must comply with the provisions laid down by the new EU Fertilising Products Regulation (EU) 2019/1009 (CELEX 32019R1009) in order to ensure that they do not present a risk to human, animal or plant health, to safety or to the environment.

Designation and CE Marking

An EU fertilising product is a fertilising product which is CE marked when made available on the market.

A manufacturer is allowed to CE mark a fertilising product only if, in accordance with the Fertilising Products Regulation (FPR), it:

• meets the requirements for the relevant product function category (Annex I)
• meets the requirements for the relevant component material category or categories (Annex II)
• is labelled in accordance with the labelling requirements (Annex III), and
• has successfully passed the relevant conformity assessment procedure (Annex IV).

Regulation (EU) 2019/1009 (CELEX 32019R1009) does not replace national legislations and does not prevent non-harmonised fertilising products from being available on the EU market in accordance with national legislations.

Compliance with the harmonised rules as laid down in the FPR remains optional. Manufacturers may decide if:

• to apply the FPR and affix the CE-mark to their products;
• to follow the rules laid down at national level in an EU country and use the mutual recognition rules;
• or to market the product both under the FPR and the national legislations, provided that the requirements under both sets of rules are met.

Classification and composition

According to the FPR, EU fertilising products are divided into different product function categories (PFCs), which will be subject to specific safety and quality requirements adapted to their different intended uses.

Component materials for EU fertilising products are also divided into different categories, subject to specific process requirements and control mechanisms. This means that it should be possible to find on the market an EU fertilising product composed of several component materials from various component material categories, where each material complies with the requirements of the category to which the material belongs.

If a fertilising product, which complies with all requirements set in Regulation (EU) 2019/1009 (CELEX 32019R1009), happens to contain a substance or microorganism known to have a pesticidal or other plant protection effect, it could still be covered by this Regulation, as long as this fertilising product does not have a pesticidal or other plant protection function within the meaning of the FPR.

Moreover, the new Regulation includes new limit values for contaminants in fertilisers.

All substances, if they are to be incorporated into a fertilizer product in the EU, must be registered by REACH in a dossier and meet minimum requirements:

• the information requirements described by REACH for the tonnage band greather than 10T/year
• a Chemical Safety Report (CSR) assessing the use of the substance as a fertilizer.

By-products belonging to Component Material Category (CMC) 11 referred to in Part II of Annex II to Regulation (EU) 2019/1009 (CELEX 32019R1009), which provide nutrients to plants or mushrooms or improve their nutrition efficiency, shall meet the criteria for agronomic efficiency and safety established in Regulation (EU) 2022/973 (CELEX 32022R0973).

Packaging and labelling obligations

Manufacturers, importers and distributors shall ensure that:

• EU fertilising products are accompanied by the information required under Annex III
• the packaging of the EU fertilising products bears a type number, batch number or other element allowing their identification or, the information is provided in an accompanying document (leaflet) where the EU fertilising products are supplied without packaging
• they indicate their name, registered trade name or registered trademark and the postal address on the packaging of the product or in the leaflet, where the product is supplied without packaging.

Such information shall be in a language easily understood by end-users and market surveillance authorities and shall be clear, understandable and legible.

Regulation (EU) 2022/973 (CELEX 32022R0973) establishes additional labeling criteria for certain EU fertilizers containing selenium (Se) or chloride (Cl-).

Conformity assessment and traceability

Conformity assessment of an EU fertilising product with the requirements laid down in this Regulation shall be carried out under the applicable conformity assessment procedure in accordance with Annex IV. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for this commitment.

Records and correspondence relating to conformity assessment procedures shall be drawn up in the official language(s) of the Member State in which the notified body carrying out these procedures is established, or in a language accepted by that body.

Before placing an EU fertilising product on the market, importers and distributors shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer and that he has complied with the obligations regarding the products' packaging and labelling.

Importers shall, for 5 years after the EU fertilising product has been placed on the market, keep a copy of the EU declaration of conformity and the technical documentation at the disposal of the market surveillance authorities.

Tests for verifying the conformity of EU fertilising products with the requirements set out in Annex I, Annex II and Annex III shall be performed in a reliable and reproducible manner.

Regulation (EU) 2022/973 (CELEX 32022R0973) establishes that compliance may be presumed in the conformity assessment procedure without verification (such as testing), at the responsibility of the manufacturer, for by-products complying with agronomic efficiency and safety criteria.

To facilitate market access, the European Union (EU) has signed Mutual Recognition Agreements (MRAs) with Australia, Canada, Japan, New Zealand, the USA, Israel or Switzerland concerning the conformity assessment of certain products, negotiated in each agreement. These MRAs lay down the conditions for reciprocal acceptance of conformity assessment results such as reports, certificates and marks to be delivered between partner countries.

Legislation

• Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L-170 25/06/2022) (CELEX 32019R1009)
• Commission Delegated Regulation (EU) 2022/973 of 14 March 2022 supplementing Regulation (EU) 2019/1009 of the European Parliament and of the Council by laying down criteria on agronomic efficiency and safety for the use of by-products in EU fertilising products (OJ L-167 24/06/2022) (CELEX 32022R0973)
• Communication from the Commission concerning the visual appearance of the label on EU fertilising products referred to in Annex III to Regulation (EU) 2019/1009 of the European Parliament and of the Council (OJ C-119 07/04/2021) (CELEX 52021XC0407(04))

Other information sources

• Mutual Recognition Agreements (MRAs): https://single-market-economy.ec.europa.eu/single-market/goods/international-aspects-single-market/mutual-recognition-agreements_en
• Specific chemicals: https://ec.europa.eu/growth/sectors/chemicals/specific-chemicals_en
• Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en
• National competent authorities responsible for the Fertilising Products Regulation: https://ec.europa.eu/docsroom/documents/51354?locale=en
• FAQs related to Regulation (EU) 2019/1009 on fertilising products (the 'Fertilising Products Regulation'): https://ec.europa.eu/docsroom/documents/50874
• The Blue Guide on the implementation of EU product rules 2022: https://single-market-economy.ec.europa.eu/news/blue-guide-implementation-product-rules-2022-published-2022-06-29_en
• Commission Expert Group on Fertilising Products: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=1320
• Standards and conformity assessment: https://trade.ec.europa.eu/access-to-markets/en/content/standards-and-conformity-assessment

The placing on the European Union (EU) market of detergents and surfactants for detergents must comply with specific provisions laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and human health.

Detergent means any substance or preparation containing soaps and/or other surfactants intended for washing and cleaning processes. They may be in any form (liquid, powder, paste, cake, etc.) and marketed for used in household, or institutional or industrial purposes.

Hence, these products are affected by provisions concerning more particularly:

• Marketing limitations based on the biodegradability of surfactants
• Labelling and mandatory product information
• Control and safeguard measures

In addition, certain surfactants used as disinfectants may be subject to the provisions laid down in Regulation (EU) 528/2012 (CELEX 32012R0528) concerning the placing of biocidal products on the EU market.

Marketing limitations based on the biodegradability of surfactants

Only the surfactants and detergents containing surfactants that meet the criteria for biodegradation as laid down in Annex III of Regulation (EC) 648/2004 (CELEX 32004R0648) may be placed on the EU market without further limitations relating to biodegradability.

However, if an industrial or institutional detergent contains surfactants for which the level of biodegradation is lower than the stipulated in Annex III but meet the biodegradability criteria of Annex II the person responsible for the placing of the product on the market may ask for derogation in accordance with a uniform procedure set out in the Regulation.

The list of surfactants that have obtained derogation, with the corresponding conditions or limitations of use, is included in Annex V.

Labelling and mandatory product information

Those responsible for the placing of a detergent on the market must, upon request, make available without delay and free of charge, to healthcare professionals (medical personnel and/or specific public body) in the Member State an ingredient datasheet. This information will be kept confidential and will be used only for medical purposes.

The following information must appear in legible, visible and indelible characters on the packaging in which the detergents are put up for sale to the consumer:

• the name and trade name of the product;
• the name or trade name and full address and telephone number of the party esponsible for placing the product on the market;
• the address, email, where available, and telephone number of the specific public body from which the ingredient datasheet can be obtained.

Specifications on the content, instructions for use, special precautions and dosage instructions must be also indicated on the packaging of detergents and cleaning products and laundry detergents.

The same information must appear on all documents accompanying detergents transported in bulk.

Besides this information, the provisions relating to the classification, labelling and packaging (CLP) of substances and mixtures laid down by with Regulation (EC) 1272/2008 (CELEX 32008R1272) are also applicable to detergents and surfactants classified as hazardous.

Control and safeguard measures

Member States' competent authorities may apply, as appropriate, all necessary control measures to detergents placed on the market which ensure the compliance of the product with the provisions of this Regulation.

If a Member State has justifiable grounds for believing that a specific detergent constitutes a risk to safety or health of humans or of animals or a risk to the environment, it may temporarily prohibit the placing on the market of that detergent in its territory or make it temporarily subject to special conditions.

Legislation

• Regulation (EC) 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L-104 08/04/2004) (CELEX 32004R0648)
• Regulation (EU) 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L-167 27/06/2012) (CELEX 32012R0528)
• Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging (CLP) of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) 1907/2006 (OJ L-353 31/12/2008) (CELEX 32008R1272)
• Updated list of approved laboratories that according to Article 8(2) of Regulation (EC) No 648/2004 of the European Parliament and of the Council on detergents are competent to carry out the tests required by the Regulation (OJ C-39 18/02/2009) (CELEX 52009XC0218(01))
• Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)

Other information sources

• Specific chemicals: https://ec.europa.eu/growth/sectors/chemicals/specific-chemicals_en
• Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en
• Summaries of the legislation and guidance documents on detergents: https://www.aise.eu
• Commission Working Group on Detergents: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=1321

The placing on the European Union (EU) market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.

The following provisions apply to these products:

• General procedures for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
• Specific provisions on the Classification, Labelling and Packaging (CLP) of substances and mixtures

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

The EU regulatory framework for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006: Regulation (EC) 1907/2006 (CELEX 32006R1907).

In principle it applies to all chemicals: not only to those used in industrial processes but also in our day-to-day life, for example in cleaning products, paints... as well as in articles such as clothing, furniture and electrical appliances.

The REACH Regulation replaces several EU laws related to chemicals and is complementary to other environmental and safety legislation, but it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)

Under this Regulation, the burden of proof for demonstrating the safe use of chemicals is transferred from Member States to the industry in order to ensure that the risks to human health and environment are avoided or adequately controlled.

The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency manages and coordinates the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.

Registration

Companies that manufacture or import one ton or more of a chemical substance annually are required to submit a registration to a central database at ECHA.

The registration procedure involves submitting a technical dossier containing information on the substance and guidance on how to handle it safely. For quantities of ten tons and more, companies also need to submit a Chemical Safety Report to document a safety assessment of the substance, demonstrating safe handling for all identified uses and manufacturing processes.

The obligation to register applies from 1 June 2008. The Regulation foresees different deadlines depending on the type and quantity of the substances produced or imported into the EU market.

Evaluation

Evaluation procedures allow authorities to determine if further testing is needed and to assess whether information provided by industry complies with the requirements (dossier evaluation). Substances suspected to pose a risk to health or the environment will be selected for substance evaluation. This may lead to actions under the authorisation or restrictions procedures.

Authorisation

Substances of very high concern (carcinogens, mutagens, substances which are persistent, bio-accumulative and toxic, etc.) are subject to an authorisation procedure. Companies who apply for authorisation need to show that the risks posed by those substances are adequately controlled or that the socio-economic benefits from their use outweigh the risks.

Restriction

Any substance on its own, in a preparation or in an article, may be subject to restrictions if its use poses unacceptable risks to health or the environment. Restrictions can be imposed on the use of a substance in certain circumstances and products, on the use by consumers or even on all uses (complete ban of a substance).

Restrictions apply to all manufacturers, importers, downstream users and distributors of a substance if the manufacture, use or placing on the market of this substance is listed in Annex XVII.

These restrictions are in line with those laid down by Regulation (EU) 2019/1021 (CELEX 32019R1021) which prohibits imports of intentionally produced POP substances listed in its Annex I, whether on their own, in preparations or as constituents of articles.

Information in the supply chain and consumer right to know

Any supplier of an article containing a hazardous substance known as 'substance of very high concern' included in Annex XIV in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.

Furthermore, companies are obliged to answer consumer inquiries about the presence of a substance of very high concern in an article, within 45 days.

Effective communication between consumers and suppliers (importers or producers) at all stages in the REACH process helps to ensure that relevant information is provided in the supply chain.

EU legislation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

Other information sources on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

General information sources on marketing requirements for chemicals

Classification, Labelling and Packaging (CLP) of substances and mixtures

Additionally, Regulation (EC) 1272/2008 (CELEX 32008R1272) requires companies to classify, label and package their chemicals before placing them on the EU market.

The scope of this Regulation covers chemical substances and mixtures which are composed of two chemical substances or more, but it shall not apply to medicinal products, cosmetic products, medical devices, waste, foodstuffs, radioactive substances, etc.

The CLP Regulation introduces throughout the EU a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties and defines the pictograms and other notices which must appear on the label.

The Regulation also takes over certain provisions of Regulation (EC) 1907/2006 (CELEX 32006R1907) (REACH) regarding the notification of classifications to the European Chemicals Agency (ECHA), the establishment of a list of harmonised classifications and the creation of a classification and labelling inventory.

Note: Substances and mixtures may be voluntary classified, labelled and packaged in accordance with Regulation (EC) 1272/2008 (CELEX 32008R1272) as amended by:

• Regulation (EU) 2024/2564 (CELEX 32024R2564) as of 20 October 2024 until the date of entry into force of this regulation on 1 May 2026
• Regulation (EU) 2024/2865 (CELEX 32024R2865) as of 10 December 2024 until the partial dates of entry into force of this regulation on 1 July 2026 and on 1 January 2027.

Note: Substances and mixtures which have been classified, labelled and packaged in accordance with sections 1.51.2 and 1.5.2.4.1 of Annex I to the Regulation (EC) 1272/2008 (CELEX 32008R1272), as applicable on 9 December 2024, and which were placed on the market before 1 July 2026 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 (CELEX 32024R2865) until 1 July 2028.

Note: Substances and mixtures which have been classified, labelled and packaged in accordance with section 1.2.1 of Annex I to the Regulation (EC) 1272/2008 (CELEX 32008R1272), as applicable on 9 December 2024 and which were placed on the market before 1 January 2027 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 (CELEX 32024R2865) until 1 January 2029.

Classification

The classification is based on categories defined in the Annex VI to the Regulation according to the degree of hazard and the specific nature of the hazardous properties. These categories include explosives, inflammable substances or mixtures, those which are highly toxic, those which are dangerous for the aquatic environment, etc.

The criteria for the classification and labelling of hazardous substances and mixtures are established in Annex I (i.e. physical, health, environmental hazards and other EU additional hazards class).

Labelling

A substance or mixture classified shall bear a label including the following elements:

• Name of the substance or mixture and/or an identification number;
• Name, address and telephone number of the supplier;
• Nominal quantity of the substance or mixture.

Labelling must also include, if applicable:

• The signal words Danger for the severe hazard categories or Warning indicating the less severe hazard;
• Hazard pictograms that shall be in the shape of a square set at a point and shall cover at least one fifteenth of the surface area of the harmonised label and the minimum area shall not be less than 1 cm2 (Annex V);
• Hazard statements (such as Fire or projection hazard, Fatal if swallowed, etc.) and supplemental information according to the specific category (Annex III);
• Precautionary statements (Annex IV).

This information shall be located together on the label in an order established by the supplier, provided that the statements are grouped by language.

The label for the hazardous substance or mixture shall be written in the official language(s) of the Member State where it is placed on the market, unless the Member State concerned provides otherwise.

The dimensions of the label will depend on the capacity of the package.

Packaging

Packaging containing hazardous substances or mixtures shall comply with the following requirements:

• Packaging must prevent any loss of the contents, except where special safety devices are prescribed;
• Materials constituting the packaging must be resistant if they come into contact with the contents;
• Packaging must be strong and solid and have sealable fastenings.

In some cases, child-resistant fastenings and tactile warnings are required.

EU legislation on Classification, Labelling and Packaging (CLP) of substances and mixtures

Other information sources on Classification, labelling and packaging (CLP) of substances and mixtures

General information sources on marketing requirements for chemicals

The placing on the European Union (EU) market of plant protection products, biocidal products and their active substances must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health.

Plant protection products

Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the rules for the authorisation of plant protection products in commercial form, the approval of their active substances as well as the rules for their placing on the market, use and control within the EU.

Plant protection products are preparations consisting of or containing active substances (chemical elements or micro-organisms, including viruses), safeners or synergists, and intended for one of the following uses:

• protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products;
• influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient;
• preserving plant products;
• destroying undesired plants or parts of plants;
• checking or preventing undesired growth of plants.

Marketing requirements and control

These products are subject to the following requirements:

Procedure and criteria for the approval of active substances

An active substance will be approved if it fulfils the procedure and criteria detailed in Annex II to the Regulation. These criteria relate to the efficacy of the substance, the relevance of metabolites, its composition, the methods of analysis, the impact on human health and the environment, ecotoxicology and residues.

Initially, the first approval is valid for a limited period which cannot exceed ten years and may be subject to certain conditions or restrictions regarding, for example, the purity of the active substance, the intended crop and the category of user.

Active substances which have been approved may be consulted on the EU Pesticides Database

Authorisation for the placing on the market of plant protection products

A plant protection product will be authorised if its active substances have been approved and the specific conditions established in the Regulation (EC) 1107/2009 (CELEX 32009R1107) and the uniform principles for evaluation laid down in Regulation (EU) 546/2011 (CELEX 32011R0546) are fulfilled.

Applications are submitted to the Member State where the product is intended to be placed on the market and will be accompanied by two dossiers containing all the information available to enable the potential effects of product on human and animal health, and the possible impact on the environment, to be assessed. Certain information provided by the applicant may be kept confidential if provide verifiable evidence that undermine his commercial interests.

A provisional authorisation for a period not exceeding three years may be granted for plant protection products containing an active substance not yet approved, is also foreseen by Regulation (EC) 1107/2009 (CELEX 32009R1107).

In addition, the provisions of mutual recognition establish that the holder of an authorisation granted in a Member State may apply for an authorisation for the same plant protection products, the same use and under comparable agriculture practices in another Member State.

Applications for authorisation of plant protection products, including for their amendment or renewal, submitted on or after 3 April 2023, must take into account the criteria set out in Annex to Regulation (EU) 2023/574 (CELEX 32023R0574) for the determination of co-formulants whose inclusion in a plant protection product is considered unacceptable.

Packaging and labelling of plant protection products

The labelling of plant protection products must comply with the requirements set out in Annex I to Regulation (EU) 547/2011 (CELEX 32011R0547) and contain the standard phrases for special risks and safety precautions protect to human or animal health or to the environment.

The products that may be mistaken for food, drink or feed must be packaged in such a way as to minimise the likelihood to be mistaken and contain components to discourage or prevent their consumption.

Moreover, the provisions on classification, labelling and packaging (CLP) of substances and mixtures laid down by Regulation (EC) 1272/2008 (CELEX 32008R1272) are also applicable to plant protection products.

Official control and emergency measures

Member States will carry out official controls in order to enforce compliance with the conditions established in Regulation (EC) 1107/2009 (CELEX 32009R1107).

European Commission may adopt emergency measures in order to restrict or prohibit the use and/or sale of an approved active substance or a plant protection product if it is likely to constitute a serious risk to human or animal health or the environment and that such risk cannot be contained satisfactorily by the Member State(s) concerned.

EU legislation on plant protection products

Other information sources on Plant Protection Products and Biocidal Products

General information sources on chemicals

Biocidal products

The biocidal products Regulation BPR, Regulation (EU) 528/2012 (CELEX 32012R0528) concerns the placing on the market and use of biocidal products within the EU.

Biocidal product is any active substance or mixture to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

The scope of BPR covers 22 different product types listed in Annex V (including disinfectants, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels) and articles treated with biocidal products (e.g. furniture treated with wood preservatives, textiles, etc.).

Other products that are sufficiently covered by existing EU legislation (medicinal products, medical devices, food and feed, additives, flavourings, cosmetic products, toys, plant protection products) are excluded from the scope of BPR.

Marketing requirements

These products are subject to the following requirements:

Authorisation of biocides

The following conditions must be met for the authorisation of biocidal products:

• the active substances are approved for the relevant product-type;
• the biocidal product, when used as authorised, is sufficiently effective, has no unacceptable effects on the target organisms, on the health of humans or animals, or on the environment;
• the physical and chemical properties of the product are considered acceptable with regard to the use and transport of the product;
• where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product;
• where nanomaterials are used in the product, the risk to human health, animal health and the environment has been assessed separately.

All biocidal products must get an authorisation before they can be made available on the market. Companies can choose between several alternative procedures, depending on their product and the number of countries where they wish to sell it:

• National authorisation and mutual recognition: Once first authorisation is granted by an EU country, the applicant can ask for the recognition of that authorisation by other EU countries;
• Union authorisation: This procedure allows companies to place certain biocidal products directly on the entire EU market;
• Simplified authorisation: To be eligible for this procedure the biocide must comply with the following conditions:
  • All the active substances contained in the product appear in Annex I of the BPR and satisfy the specific restrictions;
  • It does not contain any substance of concern or any nanomaterials;
  • It is sufficiently effective;
  • Its handling and intended use do not require personal protective equipment.

Beside, BPR provides for a simplified procedure for granting authorisation to very similar products which only vary in terms of relatively minor differences in composition and have the same use and user type (Product family).

Approval of active substances

Companies have to apply for approval of an active substance by submitting a dossier (complying with the requirements of Annex II to BPR) to European Chemicals Agency (ECHA). After the validation check has been performed, the evaluating competent authority carries out a completeness check and an evaluation within one year. The approval of an active substance is granted for a defined number of years, not exceeding ten years.

BPR also provides that substances included in Annex I to Directive 98/8/EC (CELEX 31998L0008) (previous legislation) will be included in the list of arpproved substances to be kept up to date by the European Commission.

Labelling and packaging

Companies will ensure that labels are not misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy and, in any case, do not mention the indications 'low-risk biocidal product', 'non-toxic', 'harmless', 'natural', 'environmentally friendly', 'animal friendly' or similar indications.

In addition, the label must show clearly and indelibly the following information:

• The type of formulation, the identity of every active substance and its concentration;
• The authorisation number, the identification (name and address) of the authorisation holder;
• Directions for use, frequency of application and dose rate in a manner which is meaningful and comprehensible to the user, for each use provided for under the terms of the authorisation;
• Particulars of likely direct or indirect adverse side effects and any directions for first aid;
• Directions for the safe disposal of the biocidal product and its packaging.

The provisions relating to the classification, labelling and packaging (CLP) of substances and mixtures laid down by Regulation (EC) 1272/2008 (CELEX 32008R1272) are also applicable.

EU legislation on biocidal products

Other information sources on Plant Protection Products and Biocidal Products

General information sources on chemicals

In order to reduce air pollutant emissions, Directive 98/70/EC (CELEX 31998L0070) sets fuel quality specifications and binding targets to reduce fuels greenhouse gas emissions during their life cycle.

Environmental specifications for petrol and diesel fuels

The technical specifications concern fuel for positive-ignition engines and compression-ignition engines used in road vehicles and non-road mobile machinery, tractors and recreational craft.

Petrol

Unleaded petrol can be marketed within the European Union (EU) only if it complies with the environmental specifications set out in Annex I to the Directive concerning octane level, vapour pressure, distillation by evaporation, aromatics, benzene, olefins, oxygen, oxygenates, sulphur and lead content.

In accordance with Directive 98/70/EC (CELEX 31998L0070), the marketing of leaded petrol is banned within the EU.

Diesel fuel

The environmental requirements for diesel fuel are set out in Annex II and cover cetane level, density, distillation, polycyclic aromatic hydrocarbons, sulphur content and FAME (fatty acid methyl ester) content.

Metallic additives

The presence of the metallic additive MMT (methylcyclopentadienyl manganese tricarbonyl) in fuels is limited to 2 mg of manganese per litre.

Fuels containing MMT must display a label with the text 'Contains metallic additives'. This label must be clearly visible and easily legible.

Greenhouse gas emission reduction

Fuel suppliers are responsible for gradually reducing fuel's greenhouse gas emissions according to the targets set by the Directive. In addition, they must report annually to the Member States competent authorities on the greenhouse gas intensity of the fuel supplied.

Sulphur content of gas oil and heavy fuel oil

In order to reduce the emissions of sulphur dioxide, Directive (EU) 2016/802 (CELEX 32016L0802) imposes limits on the sulphur content of certain liquid fuels: heavy fuel oil, gas oil and marine gas oil as well as marine diesel oil. These fuels can only be marketed within the EU if they do not exceed the established limits.

These requirements do not apply to fuels intended for processing prior to final combustion, for the lex.refining industry, for research and testing, etc.

In case of a sudden change of supply, Member States may be authorised by the Commission to apply higher limits for a maximum period of 6 months.

Legislation

• Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC (OJ L-350 28/12/1998) (CELEX 31998L0070)
• Directive (EU) 2016/802 of the European Parliament and of the Council of 11 May 2016 relating to a reduction in the sulphur content of certain liquid fuels (codification) (OJ L-107 25/04/2015) (CELEX 32016L0802)
• Directive (EU) 2023/2413 of the European Parliament and of the Council of 18 October 2023 amending Directive (EU) 2018/2001, Regulation (EU) 2018/1999 and Directive 98/70/EC as regards the promotion of energy from renewable sources, and repealing Council Directive (EU) 2015/652 (OJ L 2023/2413 31/10/2023) (CELEX 32023L2413)
• Notice 2020/C 127/02 on the application of Article 3 of Directive 98/70/EC with regard to the maximum vapour pressure for petrol (OJ C-127 20/04/2020) (CELEX 52020XC0420(01))
• Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L-328 21/12/2018) (CELEX 32018L2001)
• Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)

Other information sources

• Climate Action Policies: https://ec.europa.eu/clima/index_en
• Fuel Quality: https://climate.ec.europa.eu/eu-action/transport/fuel-quality_en
• Biofuels: https://energy.ec.europa.eu/topics/renewable-energy/bioenergy/biofuels_en
• EU energy policy: https://energy.ec.europa.eu/index_en
• Summaries of EU Legislation - Quality of petrol and diesel fuels: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=LEGISSUM:l28077
• Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en

The placing on the EU market of jewellery articles containing certain chemical substances, group of substances or mixtures are prohibited or severely restricted, in order to protect human health and environment, according to provisions listed on Annex XVII to Regulation (EC) 1907/2006 (CELEX 32006R1907).

According to this Regulation, the main chemical substances, group of substances or mixtures which are not allowed in jewellery articles are:

• Cadmium and its compounds in bracelets, necklaces, rings, piercing jewellery, wrist watches, wrist-wear, brooches and cufflinks.
• Nickel in earrings, necklaces, bracelets, chains, anklets, finger rings, wrist-watch cases, watch straps and tighteners.
• Lead and its compounds in bracelets, necklaces, rings, piercing jewellery, wrist watches, wrist-wear, brooches, cufflinks and any individual part or component.
• Polycyclic aromatic hydrocarbons compounds in watch-straps if any of their rubber or plastic components come into direct as well as prolonged or short-term repetitive contact with the skin or the oral cavity.
• Formaldehyde and formaldehyde-releasing substances in articles other than furniture and wood-based articles when the concentration of formaldehyde released from those articles exceeds 0,080 mg/m3.
• Synthetic polymer microparticles where the synthetic polymer microparticles are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0,01 % by weight.

The European Chemicals Agency (ECHA) manages and coordinates the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in management of chemicals across the EU.

Legislation

• Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) 793/93 and Commission Regulation (EC) 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L-396 30/12/2006) (CELEX 32006R1907)
• Communication from the Commission pursuant to Article 67(3) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ C-130 09/06/2009) (CELEX 52009XC0609(01))
• Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)

Other information sources

• European Chemicals Agency (ECHA): https://www.echa.europa.eu/
• REACH Restrictions: https://www.echa.europa.eu/regulations/reach/restriction
• Substances restricted under REACH: https://www.echa.europa.eu/substances-restricted-under-reach
• Guideline on lead and its compunds restrictions: https://www.echa.europa.eu/documents/10162/13563/lead_guideline_information_en.pdf/43269f58-7035-42ea-a396-268a17abb5ab
• REACH Restrictions: https://single-market-economy.ec.europa.eu/sectors/chemicals/reach/restrictions_en
• General information about REACH: https://ec.europa.eu/environment/chemicals/reach/reach_en.htm
• Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en

The placing on the EU market of textile and leather articles containing certain chemical substances, group of substances or mixtures are prohibited or severely restricted, in order to protect human health and environment.

Dangerous chemical substances

Acording to provisions listed on Annex XVII to Regulation (EC) 1907/2006 (CELEX 32006R1907) (REACH), the main chemical substances, group of substances or mixtures which are not allowed in textile and leather articles are:

• Tris (2,3 dibromopropyl) phosphate in textile articles intended to come into contact with the skin.
• Tris (aziridinyl) phosphinoxide in textile articles intended to come into contact with the skin.
• Polybrominated biphenyls (PBB) in textile articles intended to come into contact with the skin.
• Mercury compounds / certain new measuring devices containing mercury in the impregnation of heavy-duty industrial textiles and yarn intended for their manufacture.
• Dioctyltin (DOT) compounds in textile articles, footwear or part of footwear intended to come into contact with the skin.
• Nickel in articles intended to come into direct and prolonged contact with the skin, such as rivets buttons, tighteners, rivets, zippers and metal marks, when these are used in garments.
• Azodyes which may release one or more of the aromatic amines listed in Appendix 8, in textile and leather articles which may come into direct and prolonged contact with the skin or oral cavity.
• Nonylphenol and nonylphenol ethoxylates in textile and leather processing.
• Chromium VI compounds in leather articles intended to come into contact with the skin.
• Polycyclic aromatic hydrocarbons compounds in clothing, footwear, gloves and sporstwear if any of their rubber or plastic components come into direct as well as prolonged or short-term repetitive contact with the skin or the oral cavity.
• The substances listed in column 1 of the Table in Appendix 12 in clothing or relating accessories, footwear and other textiles intended to come into contact with human skin in a concentration, measured in homogeneous material, equal to or greater than that specified for that substance in Appendix 12.
• Formaldehyde and formaldehyde-releasing substances in articles other than furniture and wood-based articles when the concentration of formaldehyde released from those articles exceeds 0,080 mg/m3.
• Synthetic polymer microparticles where the synthetic polymer microparticles are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0,01 % by weight.
• Undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances in textiles, leather, furs and hides in clothing and related accessories for the general public.

The European Chemicals Agency (ECHA) manages and coordinates the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in management of chemicals across the EU.

Persistent organic pollutants

Persistent organic pollutants are toxic chemical substances which resist degradation.

Regulation (EU) 2019/1021 (CELEX 32019R1021) on persistent organic pollutants lays down the prohibition on imports of POP substances listed in its Annex I, whether on their own, in preparations or as constituents of articles. Therefore, POP substances listed in Annex I to this Regulation are not allowed in textile and leather articles.

Biocidal products

Biocidal product is any active substance or mixture to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. All types of biocidal products are listed and described in a Annex V to Regulation (EU) 528/2012 (CELEX 32012R0528).

Biocidal products are not allowed in textile and leather articles unless authorised in accordance with this Regulation.

Legislation

• Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) 793/93 and Commission Regulation (EC) 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L-396 30/12/2006) (CELEX 32006R1907)
• Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L-169 25/06/2019) (CELEX 32019R1021)
• Regulation (EU) 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L-167 27/06/2012) (CELEX 32012R0528)
• Communication from the Commission pursuant to Article 67(3) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ C-130 09/06/2009) (CELEX 52009XC0609(01))
• Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)

Other information sources

• European Chemicals Agency (ECHA): https://www.echa.europa.eu/
• REACH Restrictions: https://www.echa.europa.eu/regulations/reach/restriction
• Substances restricted under REACH: https://www.echa.europa.eu/substances-restricted-under-reach
• Biocidal Products Regulations - ECHA: https://www.echa.europa.eu/regulations/biocidal-products-regulation/understanding-bpr
• REACH Restrictions: https://single-market-economy.ec.europa.eu/sectors/chemicals/reach/restrictions_en
• General information about REACH: https://ec.europa.eu/environment/chemicals/reach/reach_en.htm
• Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en

The placing on the EU market of toys containing certain chemical substances, groups of substances or mixtures are prohibited or severely restricted, in order to protect human health and environment.

Directive 2009/48/EC (CELEX 32009L0048) on safety of toys restricts a number of chemical substances in toys. Annex II, part III, point 3 of the Directive provides that chemicals classified as carcinogenic, mutagenic or toxic for reproduction (CMRs) shall not be used in toys or their parts, unless certain controlled derogations listed under points 4 to 7 apply.

Toys shall not contain 55 allergenic fragances listed under point 11, while a further 11 allergenic fragances shall be labelled if they exceed a certain limit. Furthermore, point 13 sets limits for 19 metallic elements in toy materials.

Finally, Appendix C provides for specific limit values for chemicals in toys for children under 36 months, and in toys for children of any age if such toys are intended to be placed in the mouth, such as toy flutes.

According to provisions listed on Annex XVII to Regulation (EC) 1907/2006 (CELEX 32006R1907) (REACH), the main chemical substances, groups of substances or mixtures which are not allowed in toys are:

• Benzene in toys or parts of toys.
• Creosote in toys.
• Azodyes which may release one or more of the aromatic amines listed in Appendix 8, in textile or leather toys and toys which include textile or leather garments.
• Phthalates:
  • Bis (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) and benzyl butyl phthalate (BBP)s in toys.
  • Di-'isononyl' phthalate (DINP), di-'isodecyl' phthalate (DIDP) and di-n-octyl phthalate (DNOP) in toys which can be placed in the mouth by children.
• Liquid substances or mixtures which are regarded as dangerous in accordance with Regulation (EC) 1272/2008 (CELEX 32008R1272) in games or any article intended to be used as such, even with ornamental aspects.
• Polycyclic aromatic hydrocarbons compounds in toys, including activity toys, and childcare articles if any of their rubber or plastic components come into direct as well as prolonged or short-term repetitive contact with the skin or the oral cavity.
• Formaldehyde and formaldehyde-releasing substances in articles other than furniture and wood-based articles when the concentration of formaldehyde released from those articles exceeds 0,080 mg/m3.
• Synthetic polymer microparticles where the synthetic polymer microparticles are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0,01 % by weight.

The European Chemicals Agency (ECHA) manages and coordinates the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in management of chemicals across the EU.

Cosmetic toys, such as play cosmetic for dolls, have to comply with Regulation (EC) 1223/2009 (CELEX 32009R1223) on cosmetic products.

Legislation

• Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L-170 30/06/2009) (CELEX 32009L0048)
• Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) 793/93 and Commission Regulation (EC) 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L-396 30/12/2006) (CELEX 32006R1907)
• Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging (CLP) of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) 1907/2006 (OJ L-353 31/12/2008) (CELEX 32008R1272)
• Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L-342 22/12/2009) (CELEX 32009R1223)
• Communication from the Commission pursuant to Article 67(3) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ C-130 09/06/2009) (CELEX 52009XC0609(01))
• Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)

Other information sources

• European Chemicals Agency (ECHA): https://www.echa.europa.eu/
• REACH Restrictions: https://www.echa.europa.eu/regulations/reach/restriction
• Substances restricted under REACH: https://www.echa.europa.eu/substances-restricted-under-reach
• Guideline on phthalates restrictions: https://www.echa.europa.eu/documents/10162/13645/guideline_interpretation_concept_mouth_en.pdf/6f0869f4-1ff1-45ad-ac13-f623d9717718
• REACH Restrictions: https://single-market-economy.ec.europa.eu/sectors/chemicals/reach/restrictions_en
• Toys safety - DG Growth: https://ec.europa.eu/growth/sectors/toys/safety_en
• General information about REACH: https://ec.europa.eu/environment/chemicals/reach/reach_en.htm
• Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en

Imports of certain chemical substances frequently used in the illicit manufacture of narcotic drugs and psychotropic substances (precursors) are subject to control requirements in order to prevent their illicit use. These requirements refer to the following aspects:

• Licensing and or registration of operators; appointment of a responsible officer
• Import documentation and labelling
• Provision of information
• Import authorisation

Regulation (EC) 111/2005 (CELEX 32005R0111) on drug precursors establishes a list of 'scheduled substances' organised according to the type of control envisaged.

These controls do not apply to medicinal products, with the exception of those substances listed in category 4 of the Annex, mixtures, natural products containing scheduled substances in such a way that they cannot be easily used or extracted.

Nevertheless, the competent authorities shall prohibit the introduction of non-scheduled substances where there is sufficent evidence that those substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances.

Licensing and registration of operators; appointment of a responsible officer

Operators engaged in the import of scheduled substances listed in category 1 of the Annex shall be required to obtain a licence from the Member State in which they are established to qualify for this activity.

Operators engaged in the import of scheduled substances listed in category 2 of the Annex are required to register and update with the competent authorities the addresses of the premises where they conduct these activities.

Pharmacies, dispensaries of veterinary medicine, customs, police, armed forces and official laboratories of competent authorities may be exempted from the requirements of licensing and registration in so far as these operators use drug precursors within the scope of their official duties.

Operators must appoint an officer responsible for the import in scheduled substances of these categories and notify the competent authorities of the name and contact details of that officer. This person shall represent the operator and ensure that import activities comply with the pertinent legislation.

Import documentation and labelling

Import operations involving scheduled substances of all categories, with the excepction of those substances listed in category 4, shall be properly documented. All import documents, such as summary declarations, customs declarations, invoices, cargo manifests, transport and other shipping documents, shall contain sufficient information to identify:

• the name of the scheduled substance (as given in the Annex to the Regulation), followed by the term 'DRUG PRECURSORS' in the case of a mixture or a natural product;
• the quantity and weight of the scheduled substance, and, where applicable, the percentage contained in a mixture or a natural product;
• the names and addresses of the exporter, the importer, the ultimate consignee and, where applicable, the person involved in the intermediary activities.

These documents shall be kept, electronically or in paper form, for three years from the end of the year in which the operation took place, and must be readily available for inspection.

Labels that may be affixed on any packaging containing scheduled substances, with the exception of those substances listed in category 4, must show the names of these substances as given in the Annex.

Provision of information

Operators shall notify the competent authorities of any circumstances which suggest that scheduled substances may be diverted for the illicit manufacture of narcotic drugs or psychotropic substances.

Once a year they shall provide the competent authorities with information in summary form about all their imports of scheduled substances of category 1 or, where substances of category 2 enter into a free zone, are placed into a suspensive procedure other than transit, or released for free circulation.

Import authorisation

Imports of scheduled substances listed in category 1 of the Annex are subject to an import authorisation which shall be issued by the competent authorities of the Member State where the importer is established according to the form given in Annex IV to Regulation (EU) 2015/1013 (CELEX 32015R1013).

The import authorisation shall be made out in four copies and must accompany the consignment from the point of entry into the Europen Union (EU) to the premises of the importer or ultimate consignee.

An import authorisation shall not be granted for more than two scheduled substances.

Legislation

• Council Regulation (EC) 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors (OJ L-22 26/01/2005) (CELEX 32005R0111)
• Commission Implementing Regulation (EU) 2015/1013 of 25 June 2015 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors (OJ L-162 27/06/2015) (CELEX 32015R1013)
• Commission Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commission Regulation (EC) No 1277/2005 (OJ L-162 27/06/2015) (CELEX 32015R1011)

Other information sources

• Drug precursors control: https://taxation-customs.ec.europa.eu/customs-4/prohibitions-and-restrictions/drug-precursors-control_en
• Chemicals legislation: https://ec.europa.eu/growth/sectors/chemicals/legislation/
• Summaries of EU legislation - Drug precursors: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=LEGISSUM:120302_2