Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety establishes the European Union's regulatory framework for food safety.

This Regulation was further developed and complemented by several provisions, collectively referred to as the "hygiene package", including Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs, Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin, as well as Regulation (EC) No 854/2004 and Regulation (EC) No 882/2004, now repealed by Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on controls and other official activities performed to ensure the application of feed and food law, animal health and welfare, plant health and plant protection rules.

In addition, since 14 December 2019, Commission Delegated Regulation (EU) 2019/624 of 8 February 2019 and Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 regulate the official control of products of animal origin intended for human consumption.

There are also implementing regulations of the hygiene package, which remain in force such as:

• Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs.
• Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulations (EC) No 854/2004 and 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and 854/2004.
• Commission Implementing Regulation (EU) 2015/1375 of 10 August 2015 laying down specific rules on official controls for Trichinella in meat.

Given the existence of this Community regulatory framework, it became necessary to adopt, at the Spanish level, a provision clarifying the regulatory framework, which resulted in the publication of Royal Decree 640/2006, of 26 May, which regulates certain conditions for the application of Community provisions on the hygiene, production and marketing of foodstuffs.

More than a decade after the publication of the hygiene package regulations and the aforementioned Royal Decree, taking into account the experience gained, scientific advances and developments in food production and marketing systems, new demands from society and the unity of the internal market, it was necessary to revise the national regulations on food hygiene.

Thus, Royal Decree 640/2006 has been repealed and, since 11 December 2020, Royal Decree 1086/2020, which regulates and relaxes certain conditions for the application of European Union provisions on the hygiene of the production and marketing of foodstuffs and regulates activities excluded from its scope of application, has been applicable.

With the publication of this regulation, Spain facilitates the harmonised application of EU regulations throughout the national territory and allows the objectives of the hygiene regulations to be achieved in certain food establishments which, due to their specific nature, size or production capacity, require a differentiated consideration.

In addition, it integrates, simplifies and adapts the national regulations on food hygiene that were scattered in various royal decrees, most of them prior to the hygiene regulations, and which this regulation repeals.