8. Safety Parameters

Provision, Limits, Testing Methods

Foodstuffs/General Foods

Two types of microbiological criteria are set out in Regulation (EC) No. 2073/2005 [1] (as amended) and include criteria for both pathogens and indicator organisms by specific food categories: 

• Food safety criteria defining the acceptability of a product or a batch. They are applicable to foodstuffs placed on the market and throughout the shelf-life of the food. 

• Process hygiene criteria defining the acceptability of the process. These apply only during the manufacturing process.

Provision, Limits, Testing Methods

Foodstuffs/General Foods

The principles of EU legislation on contaminants in food are contained in Regulation 315/93/EEC [2]:

• Food containing a contaminant to an amount unacceptable from the public health viewpoint, and in particular at a toxicological level, is not to be placed on the market.
• Contaminant levels must be kept as low as can reasonably be achieved following recommended good working practices.
• Maximum levels must be set for certain contaminants in order to protect public health.

Regulation EC 1881/2006 [3] lays down maximum levels for certain contaminants in foodstuffs, including lead, cadmium, mercury, and inorganic tin. It does not cover radioactive substances. 

Regulation EC 333/2007 [4] covers the methods of sampling and analysis for the official control of the maximum levels of these metals. Surveillance for residues of chemical elements in foods of animal origin is specified in Council Directive 96/23/EC [5].

Maximum levels for certain contaminants in food are set in Commission Regulation (EU) 2023/915 [6]. Maximum levels in certain foods are set for the following contaminants effective as of April 25, 2003. The regulation 2023/915 replaces 1881/2006:

• Mycotoxins (aflatoxins, ochratoxin A, patulin, deoxynivalenol, zearalenone, fumonisins, citrinine, ergot sclerotia, and ergot alkaloids).
• Plant toxins (erucic acid, tropane alkaloids, hydrocyanic acid, pyrrolizidine alkaloids, opium alkaloids, Δ9-THC).
• Metals (lead, cadmium, mercury, arsenic, inorganic tin).
• Halogenated persistent organic pollutants (dioxins, dioxin-like PCBs, non-dioxin-like PCBs; perfluoroalkyl substances: PFOS, PFOA, PFNA, PFHxS).
• Processing contaminants (polycyclic aromatic hydrocarbons (PAH): benzo(a)pyrene, sum of 4 PAHs; 3-monochloropropane-1,2-diol (3-MCPD), glycidyl fatty acid esters).
• Other contaminants (nitrates, melamine, perchlorate).

Provision, Limits, Testing Methods

Foodstuffs/General Foods

A 'pesticide' is something that prevents, destroys, or controls a harmful organism ('pest') or disease, or protects plants or plant products during production, storage, and transport.

The term includes, amongst others: herbicides, fungicides, insecticides, acaricides, nematicides, molluscicides, growth regulators, repellents, rodenticides, and biocides.

These active substances have one of the following functions:

• Protect plants or plant products against pests/diseases, before or after harvest
• Influence the life processes of plants (such as substances influencing their growth, excluding nutrients);
• Preserve plant products
• Destroy or prevent the growth of undesired plants or parts of plants

They may also contain other components including safeners and synergists.

The EU has a database of pesticides [7] with their Maximum Residue Levels in food products.

Provision, Limits, Testing Methods

Foodstuffs/General Foods

Regulation (EC) 470/2009 [9]

Consumer safety is evaluated by maximum residue limits (MRLs). Regulation 37/2010 [10] shows in Annex Table 1, the allowed pharmacologically active substances and their classification with MRL. In addition, it indicates if it can be used ‘in animals which milk is produced for human consumption’.

Provision, Limits, Testing Methods

Foodstuffs/General Foods

All food contact materials (FCM) used for imported food must comply with Regulation (EC) No 1935/2004[11] 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 [12], and specific Union legislation on certain materials, including on plastic and ceramics, as well as with National legislation on other materials.

An official guidance document on FCM compliance for EU [13] is available.

Regarding Plastic Materials: Regulation (EU) No 10/2011 [14] 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.

Additional note:

The EU's general food safety principles for imported products are defined in Regulation (EC) No 178/2002 [15]. Article 11 mandates that 'Food and feed imported into the Community for placing on the market within the Community shall comply with the relevant requirements of food law or conditions recognized by the Community to be at least equivalent thereto or, where a specific agreement exists between the Community and the exporting country, with requirements contained therein.'

Article 19 of this Regulation defines the responsibilities of food importers: 'If a food business operator considers or has reason to believe that a food which it has imported is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that initial food business operator and inform the competent authorities thereof.'

As a result, the imported food products must be produced under at least equivalent standards as all safety parameters presented above.