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    Overview of Packaging Legislation in Spain
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    Overview of Packaging Legislation in Spain

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    Packaging Legislation
    Spain

    The below version control table serves to document all updates made to the report. The purpose is to ensure the information is always accurate and up-to-date.

    Version Number
    Content Creation Date
    		Publishing DateSection(s) Updated & Reason(s) for Update
    V0
    5 December 2023
    		26 January 2024N/A (new report)
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    1. Overview of the Current Packaging Legislation

    In Spain, the Spanish Agency for Food Security and Nutrition (AESAN) [1] integrates and performs, within the competence framework of the General State Administration, the functions related to food security and healthy nutrition in the country. It is an Autonomous Agency, organically attached to the Ministry of Consumer Affairs, through the General Secretariat of Consumer Affairs and Gambling and functionally to the Ministry of Consumer Affairs, the Ministry of Health, and the Ministry of Agriculture, Fisheries and Food.

    As food packaging and food contact materials are a topic closely linked to food safety, the control, surveillance, and regulation are under the scope of AESAN. 

    Considering that Spain is a Member State of the European Union (EU), the packaging and food contact materials in that country are regulated at both levels through direct adoption of the EU regulations and local Royal Decrees. 

    All food contact materials (FCM) must comply with Regulation (EC) No 1935/2004 [2] on materials and articles intended to come into contact with food when placed on the European market.  In addition to this Regulation, all FCM must be manufactured in accordance with Good Manufacturing Practices (GMP) as described in Commission Regulation (EC) No 2023/2006 [3], and specific Union legislation on certain materials (see below), as well as with National legislation on other materials.

    Overall the general requirements for food contact material are as follows (Article 3 of Regulation (EC) No 1935/2004):

    1. Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities that could:
      1. endanger human health; or
      2. bring about an unacceptable change in the composition of the food; or
      3. bring about a deterioration in the organoleptic characteristics thereof.
    2. The labeling, advertising, and presentation of a material or article shall not mislead the consumers.

    General requirements for the authorization of substances and the Application for authorization of a new substance are described in Articles 8 and 9 respectively.

    In addition, 

    1. Materials and articles, that are not yet in contact with food when placed on the market, shall be accompanied by:
      1. the words ‘for food contact’, or a specific indication as to their use, such as coffee machine, wine bottle, soup spoon, or the following symbol (from Annex II); and 

    1. if necessary, special instructions to be observed for safe and appropriate use; and
    2. the name or trade name and, in either case, the address or registered office of the manufacturer, processor, or seller responsible for placing on the market established within the Community; and
    3. adequate labeling or identification to ensure traceability of the material or article, as described in Article 17; and
    4. in the case of active materials and articles, information on the permitted use or uses and other relevant information such as the name and quantity of the substances released by the active component so as to enable food business operators who use these materials and articles to comply with any other relevant Community provisions or, in their absence, national provisions applicable to food, including the provisions on food labeling.
    1. The information referred to in paragraph 1(a) shall not, however, be obligatory for any articles which, because of their characteristics, are clearly intended to come into contact with food.
    2. The information required by paragraph 1 shall be conspicuous, clearly legible, and indelible.

    Special requirements for active and intelligent materials and articles are laid down in Commission Regulation (EC) No 450/2009 [4].

    More specifically on certain substances: 

    Plastic materials

    • Commission Regulation (EU) No 2022/1616 [5] on recycled plastic materials and articles intended to come into contact with foods. It lays down rules for:
      1. the placing on the market of plastic materials and articles falling within the scope of Article 1(2) of Regulation (EC) No 1935/2004, containing plastic originating from waste or manufactured therefrom;
      2. the development and operation of recycling technologies, processes, and installations, to produce recycled plastic for use in those plastic materials and articles;
      3. the use in contact with food of recycled plastic materials and articles and of plastic materials and articles which are intended to be recycled.

    • Regulation (EU) No 10/2011 [6] sets out rules on the composition of plastic FCMs and establishes a Union List of substances that are permitted for use in the manufacture of plastic FCMs. The Regulation also specifies restrictions on the use of these substances and sets out rules to determine the compliance of plastic materials and articles.

    • Commission Regulation (EU) No 284/2011 [7] lays down specific conditions and detailed procedures for the import of polyamide and melamine plastic kitchenware originating in or consigned from the People’s Republic of China and Hong Kong Special Administrative Region, China. 

    National Provisions: 

    Royal Decree 846/2011 of 17 June [8] established the conditions to be met by raw materials based on recycled polymeric materials for use in materials and articles intended to come into contact with foodstuffs. This Royal Decree establishes, on a transitional basis, the conditions to be met by raw materials based on recycled polyethylene terephthalate (PET) obtained in Spain for use in materials and articles intended to come into contact with food, until the Community decisions provided for in Article 13(6) of Commission Regulation (EC) No 282/2008 of 27 March 2008 on recycled plastic materials and articles intended to come into contact with food and amending Regulation (EC) No 2023/2006 are adopted.

    In addition, this establishes the conditions for the rest of the raw materials based on recycled polymeric materials for their use in materials and articles intended to come into contact with foodstuffs until they are regulated at the Community or national level.

    Polymeric Materials

    Commission Regulation (EU) No 2018/213 [9] on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials. It foresees migration limits. 

    National Provisions: 

    1. Resolution of 4 November 1982 [10] approving the positive list of substances intended for the manufacture of macromolecular compounds, the list of maximum migrations in release tests for some of them, the purity conditions for coloring matters used in the same products, and the list of polymeric materials suitable for the manufacture of packaging and other utensils which may come into contact with foodstuffs and foodstuffs.  This Resolution is currently revoked, except for waxes and carriers for the production of polymerization.
    2. Royal Decree 847/2011 of 17 June 2011 [11] established the positive list of substances permitted for the manufacture of polymeric materials intended to come into contact with foodstuffs. This piece of regulation lays down: 
      1. The positive list of monomers, additives, and other starting substances authorized for the manufacture of polymeric materials and articles intended to come into contact with foodstuffs.
      2. Their maximum permitted migrations obtained in migration tests and determine the conditions for testing them.
      3. The conditions of identity and purity of coloring matter.
    3. Royal Decree 773/2023 of 3 October [12] on the regulation of processing aids used in the production and processing of foodstuffs.  This provides for the list of processing aids to be used in the food industry, including in the packaging and food contact materials. 

    Epoxy Derivatives: BADGE, BFDGE, NOGE

    Commission Regulation (EC) No 1895/2005 [13] on the restriction of the use of certain epoxy derivatives in materials and articles intended to come into contact with food.  This Regulation applies to materials and articles, including active and intelligent food contact materials and articles, as referred to in Article 1(2) of Regulation (EC) No 1935/2004, which are manufactured with or contain one or more of the epoxy derivatives listed therein. 

    Ceramic 

    Council Directive 84/500/EEC [14] relating to ceramic articles intended to come into contact with foodstuffs defines the method for the determination of lead and/or cadmium ions extracted by the simulated food when in contact with the use surface of the ceramic materials. Furthermore, it establishes the maximum allowable release limits as well as the obligation for all ceramic articles not yet in contact with food to be accompanied by a written declaration certifying their conformity with the standards applicable to them.

    This Directive is transcribed into Spanish legislation as Royal Decree 891/2006 [15] approving the technical-sanitary rules applicable to ceramic articles for food use. 

    Regenerated Cellulose

    Commission Directive 2007/42/EC [16] on materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs. This Directive is transcribed into Spanish legislation as Royal Decree 1413/1994, of 25 June 1994 [17] approving the Technical-Sanitary rules on materials and articles of regenerated cellulose film for food use. 

    Rubber: N-Nitrosamines 

    Commission Directive 93/11/EEC [18] on the release of N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers. This Directive is transcribed into Spanish legislation as Royal Decree 1184/1994 [19]. 

    Metal 

    No directly applicable Community (EU) provisions or national regulations have been identified for food packaging or food contact materials made of metals.

    Finally, an official guidance document on FCM compliance for the EU is available [20] as well as recommendations from the European Commission on:

    • the monitoring of mineral oil hydrocarbons in food and in materials and articles intended to come into contact with food [21]
    • a coordinated control plan with a view to establishing the prevalence of certain substances migrating from materials and articles intended to come into contact with food [22].
    Conclusion
    1. In Spain, the regulatory framework for packaging and food contact materials is structured on the EU and local regulations. 
    2. Spain has regulations for plastic materials, polymeric materials, epoxy derivatives (BADGE, BFDGE, NOGE), ceramics, regenerated cellulose, and rubber: n-nitrosamines. 
    3. No directly applicable Community (EU) provisions or national regulations have been identified for food packaging or food contact materials made of metals.
    4. There are no expected regulatory developments/changes.

    2. References

    1. Website of the Spanish Agency for Food Security and Nutrition (AESAN)

    https://www.aesan.gob.es/AECOSAN/web/home/aecosan_inicio.htm

     

    2. Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food

    https://eur-lex.europa.eu/eli/reg/2004/1935/oj 

     

    3. Commission Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food

    https://eur-lex.europa.eu/eli/reg/2006/2023/oj 

     

    4. Commission Regulation (EC) N° 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food

    https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32009R0450 

     

    5. Commission Regulation (EU) 2022/1616 of 15 September 2022 on recycled plastic materials and articles intended to come into contact with foods, and repealing Regulation (EC) No 282/2008

    https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02022R1616-20220920

     

    6. Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food 

    https://eur-lex.europa.eu/eli/reg/2011/10/oj 

     

    7. Commission Regulation (EU) No 284/2011 of 22 March 2011 laying down specific conditions and detailed procedures for the import of polyamide and melamine plastic kitchenware originating in or consigned from the People’s Republic of China and Hong Kong Special Administrative Region, China

    https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32011R0284 

     

    8. Royal Decree 846/2011 of 17 June establishing the conditions to be met by raw materials based on recycled polymeric materials for use in materials and articles intended to come into contact with foodstuffs

    https://www.boe.es/buscar/act.php?id=BOE-A-2011-11827 

     

    9. Commission Regulation (EU) No 2018/213 of 12 February 2018 on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011

    https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32018R0213 

     

    10. Resolution of 4 November 1982 approving the positive list of substances intended for the manufacture of macromolecular compounds, the list of maximum migrations in release tests for some of them, the purity conditions for colouring matters used in the same products and the list of polymeric materials suitable for the manufacture of packaging and other utensils which may come into contact with foodstuffs and foodstuffs

    https://www.boe.es/buscar/doc.php?id=BOE-A-1982-30787#analisis

     

    11. Royal Decree 847/2011 of 17 June 2011 establishing the positive list of substances permitted for the manufacture of polymeric materials intended to come into contact with foodstuffs

    https://www.boe.es/diario_boe/txt.php?id=BOE-A-2011-11828 

     

    12. Royal Decree 773/2023 of 3 October on the regulation of processing aids used in the production and processing of foodstuffs

    https://www.boe.es/buscar/doc.php?id=BOE-A-2023-20563 

     

    13. Commission Regulation (EC) No 1895/2005 of 18 November 2005 [19] on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food

    https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32005R1895

     

    14. Council Directive 84/500/EEC of 15 October 1984 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs

    https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:31984L0500

     

    15. Royal Decree 891/2006 of 21 July 2006 approving the technical-sanitary rules applicable to ceramic articles for food use

    https://www.boe.es/buscar/act.php?id=BOE-A-2006-13274

     

    16. Commission Directive 2007/42/EC of 29 June 2007 on materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs

    https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32007L0042

     

    17. Royal Decree 1413/1994, of 25 June 1994 approving the Technical-Sanitary rules on materials and articles of regenerated cellulose film for food use

    https://www.boe.es/buscar/act.php?id=BOE-A-1994-18669 

     

    18. Commission Directive 93/11/EEC of 15 March 1993 the release of N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers

    https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:31993L0011 

     

    19. Royal Decree 1184/1994 of 3 June 1994 laying down basic rules for the determination of N-nitrosamines and substances capable of converting into N-nitrosamines (N-nitrosatable substances) which may be released from rubber teats and soothers

    https://www.boe.es/boe/dias/1994/07/06/pdfs/A21598-21599.pdf 

     

    20. EU Guidance document on FCM compliance

    https://food.ec.europa.eu/safety/chemical-safety/food-contact-materials/legislation_en 

     

    21. Commission Recommendation (EU) 2017/84 of 16 January 2017 on the monitoring of mineral oil hydrocarbons in food and in materials and articles intended to come into contact with food

    https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017H0084 

     

    22. Commission Recommendation (EU) 2019/794 of 15 May 2019 on a coordinated control plan with a view to establishing the prevalence of certain substances migrating from materials and articles intended to come into contact with food

    https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019H0794


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