8. Safety Parameters

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8. Safety Parameters

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General Foods
United Kingdom (UK)

This section provides the safety parameters (microbiological, contaminants, heavy metals, pesticides, veterinary residues, and food contact materials).

8.1 Microbiological Standards

Food must comply with the general rules on the hygiene of food established in Regulation (EC) No 852/2004 (Articles 3 to 6) [1]. Among other food hygiene requirements, this Regulation states that it is the responsibility of food business operators to ensure due diligence measures are in place and documented in Hazard Analysis and Critical Control Point (HACCP) or food safety management systems, in order to mitigate the risk in food.

Microbiological criteria for foods authorized in the EU are defined in Regulation (EC) No 2073/2005 [2], it lays down food safety criteria for relevant foodborne bacteria, their toxins, and metabolites, such as Salmonella, Listeria monocytogenes, Enterobacter sakazakii, staphylococcal enterotoxins, and histamine in specific foods. These criteria define the acceptability of a product or a batch of food applicable to products placed on the EU market. In addition, this Regulation lays down certain process hygiene criteria to indicate the correct functioning of the production process.

For ingredients of animal origin, in accordance with Articles 1(2) and 6(4) of Regulation (EC) No 853/2004 [3], processed products of animal origin (e.g. egg powder, pasteurized cream, concentrated meat juice) used to prepare composite products shall be obtained and handled in accordance with the requirements of this Regulation. To guarantee this compliance, the composite products must be manufactured with processed products of animal origin produced in EU-approved establishments located either in EU Member States or in third countries authorized for entry into the European Union of those processed products of animal origin.

8.2 Contaminants and Heavy Metals

Commission Regulation (EC) No 1881/2006 [Commission Regulation (EC) No 1881/2006 [4] establishes the maximum levels of the following contaminants:

Mycotoxins: aflatoxins, ochratoxin A, fusarium-toxins, patulin, citrinin (e.g. in spices, dry fruits)
Metals: cadmium, lead, mercury, inorganic tin, arsenic (e.g. in fats and oil, cocoa)
Dioxins and Polychlorinated Biphenyls (PCBs) (e.g. fats and oil)
Polycyclic Aromatic Hydrocarbons (PAH) (e.g. vegetable oil or coconut oil)
3-MCPD (e.g. soy sauce)
Melamine (e.g. all foods)
Erucic acid (e.g. vegetable oil)
Nitrates (e.g. spinach)

Melamine is the only contaminant for which there is a limit in all food, except infant formula and follow-on formula (2.5 mg/kg).

8.3 Pesticides

All foodstuffs intended for humans sold in the EU are subject to a maximum residue level (MRL) of pesticides, as defined in Regulation (EC) No 396/2005 [6]. These MRLs include:

MRLs which are specific to particular products intended for human or animal consumption;
A general MRL that applies where no specific MRL has been set (a ‘default level’ of 0.01 mg/kg).

A database listing the MRLs specific to a particular product and the authorized and non-authorized pesticide substances is available [7].

An official website provides guidance on EU legislation on MRLs [8].

8.4 Veterinary Standards

Shelf-stable composite products (foodstuffs containing both products of plant origin and processed products of animal origin that do not require to be stored in a fridge before opening e.g. mayonnaise containing egg or savory/sweet sauce containing dairy ingredients or honey) may enter the EU, provided they respect the following EU animal health rules:

The dairy products and the egg products contained in the composite product have been subjected to a risk mitigation treatment (e.g. inactivation of highly pathogenic avian influenza for egg products), at least equivalent to those set out in Annex XXVII and Annex XXVIII of Commission Delegated Regulation (EU) 2020/692 [9].
The processed products of meat origin contained in the composite products must comply with the relevant requirements for entry into the EU laid down in Commission Delegated Regulation (EU) 2020/692. They have been produced either in the EU, in the country of production of the composite product, or in another listed country provided that they have not undergone any risk-mitigating treatment different from those applicable in the country of production of the composite product.

The third country of origin of the processed product of animal origin contained in the composite product must be listed in the relevant EU lists (laid down in Commission Implementing Regulations (EU) 2021/404 [10] or (EU) 2021/405) [11].

In conclusion, for animal health reasons, the processed products of animal origin must have been obtained either:

in the same listed third country of the composite product manufacture; or
in the EU; or
in a third country that is listed for entry into the EU of those products without them undergoing a specific risk-mitigating treatment if the third country where the composite product is manufactured is also listed for entry into the EU under the same conditions.

UK – The commission implementing regulation EU 2021/634 amends implementing regulation (EU) 2021/404 as regards transitional arrangements, the entries of the UK and the Crown Dependencies of Guernsey, the Isle of Man and Jersey, and the list of third countries authorized for the entry into the Union of dairy products required to undergo a specific risk-mitigating treatment against foot and mouth disease.

8.5 Food Contact Materials

All food contact materials (FCM) used for imported food must comply with Regulation (EC) No 1935/2004 [12] 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, Commission Regulation (EC) No 2023/2006 [13], and specific Union legislation on certain materials, including plastic and ceramics, as well as with National legislation on other materials.

An official guidance document on FCM compliance for the EU is available [14].

Regarding Plastic Materials: Regulation (EU) No 10/2011 [1], 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.

8.6 References

1. Regulation (EC) No 852/2004 on the hygiene of foodstuffs

https://eur-lex.europa.eu/eli/reg/2004/852/oj

2. Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs

https://eur-lex.europa.eu/eli/reg/2005/2073/oj

3. Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin

https://eur-lex.europa.eu/eli/reg/2004/853/oj

4. Commission Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs

https://eur-lex.europa.eu/eli/reg/2006/1881/oj

5. Contaminants in Food (England) Regulation 2013

https://www.legislation.gov.uk/uksi/2013/2196/contents/made

6. Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin

https://eur-lex.europa.eu/eli/reg/2005/396/oj

7. Pesticides database on MRLs, authorized and non-authorized pesticides substances

https://food.ec.europa.eu/plants/pesticides/eu-pesticides-database_en

8. Website providing guidance on EU legislation on MRLs

https://food.ec.europa.eu/plants/pesticides/maximum-residue-levels/eu-legislation-mrls_en

9. Commission Delegated Regulation (EU) 2020/692 as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin

https://eur-lex.europa.eu/eli/reg_del/2020/692/oj

10. Commission Implementing Regulation (EU) 2021/404

https://eur-lex.europa.eu/eli/reg_impl/2021/404/oj

11. Commission Implementing Regulation (EU) 2021/405

https://eur-lex.europa.eu/eli/reg_impl/2021/405/oj

12. 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

13. 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

14. EU Guidance document on FCM compliance

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

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