References to relevant EU and international legislation and internet links

There are numerous legal requirements on health, safety, environment and security having an impact on product stewardship. The list below covers some regulations at UN and EU level. The list is not a complete list of all regulations, and later revisions and amendments may have been issued. Electronic versions of EU legislation can be downloaded from EURLEX.

 

UN Recommendations

UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Ninth Revised Edition, ISBN 978-92-1-117252-2, 2021 (includes harmonized criteria for classifying substances and mixtures according to their health, environmental and physical hazards and harmonized hazard communication elements, including requirements for labelling and safety data sheets)

Recommendations on the Transport of Dangerous Goods: Manual of Tests and Criteria, Seventh Revised Edition, ISBN 978-92-1-130394-0, 2019.

International Maritime Dangerous Goods Code (IMDG) 2020 Edition, IMO Publications, ISBN 978-92-801-0050-1, 2020.

International Maritime Solid Bulk Cargoes (IMSBC) Code and Supplement, 2020 Edition ISBN 978-92-801-1719-6, 2020.

Recommendations on the Transport of Dangerous Goods - Model Regulations, Rev. 22, ISBN 978-92-1-139188-6, 2021.

Agreement Concerning the International Carriage of Dangerous Goods by Road (ADR), ISBN 978-92-1-139179-4, 2021.

Convention concerning International Carriage by Rail (COTIF), 2010.

  • Appendix B: Uniform Rules concerning the Contract for International Carriage of Goods by Rail (CIM), 2016.
  • Appendix C: Regulations concerning the International Carriage of Dangerous Goods by Rail (RID), 2021.
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    European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways (ADN), ISBN 978-92-1-139182-4, 2021

     

    EU Legislation

    Regulation on Fertilizing Products

    Since July 16, 2022 a new fertilizing product regulation apply namely Regulation (EU) 2019/1009 on the making available on the market of EU fertilizing products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003

    This new Fertilizer Product Regulation (FPR) radically changes the way that fertilizers are receiving the CE mark and its labelling requirements provided on the products. At the same time, it provides the legal frame to market within the EU on a very wide range of fertilizing products such as organic fertilizers, organo-mineral fertilizers, growing media or biostimulants – provided that they comply with set requirements as well as the environmental and safety requirements of the new legislation. There is also the inclusion of industry by-products in the scope of the regulation, provided they are meeting the high level of set criteria and requirements.

    The FPR will be regulating both the end characteristics (contaminants and nutrient levels) as well as the input materials contained in every fertilizing product (e.g. REACH registration). It implies what is called the concept of CMC (Component Material Category) and PFC (Product Function Category) in order to apply for CE marking, a toolbox of measures has been implemented with different pathways depending on the product category and its content. This is to be understood as a ‘conformity assessment’, i.e. a process demonstrating whether specified requirements relating to a fertilizing product are fulfilled and has to be laid down in the technical documentation. The concept of notified bodies has also been developed as an additional player within the scope of the new FPR and they are considered to be the conformity assessment body officially designated by the national body to carry out the procedures for conformity assessment within the meaning of FPR. Depending on the nature of the product several assessment modules have been defined of which for some the assessment by a notified body is obligatory. Specific and more comprehensive rules have also been developed on the labelling requirements including a broader window of opportunities for more information is given with set of minimum requirements and it will cover instructions for intended use including e.g. application rates, timing and frequency.

    Some extra links, documents and guidance:Consolidated version of FPR Commission Guidance on labelling

     

    REACH and Safety Data Sheets

    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) is a very far reaching legislation which has put in place several requirements on those who deal in chemicals. It has amended requirements for the provision of safety data Sheets. Guidance on the compilation of safety data sheets was published by the European Chemicals Agency (ECHA) in December 2011. It seeks to cover most of the requirements of sections 1 to 16 as defined in Annex II of EC 1907/2006 and as amended by Regulation (EU) No 453/2010; later superseded by EU 878/2020, and the latest guidance on SDSs published in April 2021.

     

    Seveso Directive

    Seveso III Directive (2012/18/EU)

     

    Industrial Emissions Directive (IED)

    The EU has a set of common rules on permitting for industrial installations. The rules are set out in the Directive 2010/75/EU of the European Parliament and of the Council on industrial emissions of 24 November 2010 which replaces the Integrated Pollution Prevention and Control (IPPC) Council Directive 96/61/EC. In essence, the Directive is about minimizing pollution from various point sources throughout the European Union. All installations covered by Annex I of the Directive are required to obtain an authorization (permit) from the authorities in the EU countries. Unless they have a permit, they are not allowed to operate. The permits must be based on the concept of Best Available Techniques (or BAT).

    EU Best Available Technique Reference Document Ammonia, Acids and Fertilizers, August 2007

     

    GHG Emission and Emission Trading
    Directive 2003/87/EC: Establishing a scheme for Greenhouse Gas allowance trading within the Community and amending Council Directive 96/61/EC

    Air Pollution
    Several EU regulations has been established for the prevention of air pollution

    Workplace Safety (Occupational Exposure Limits Levels) and Personal Protective Equipment
    Several EU regulations has been established for the protection of workers

    Machinery Protection
    The Machinery Directive 98/37/EC provides the regulatory basis for the harmonisation of the essential health and safety requirements for machinery at European Union level.

    Transport Safety Adviser and Security Issues
    Council Directive 96/35EC on the appointment a vocational qualification of safety advisers for the transport of dangerous goods by road, rail and inland waterway

    Regulation EC 725/2004 on enhancing ship and port facility security

    Directive 2005/65/EC on enhancing port security

    ETS Directives

    Explosive Precursors Directives