32005R0396

WHAT IS THE AIM OF THE REGULATION?

All foodstuffs intended for human or animal consumption in the European Union (EU) are subject to a maximum residue level (MRL) of pesticides in order to protect animal and human health. EU law regulates which MRLs apply to different products and establishes a default MRL where no specific MRL has been established.

Regulation (EC) No 396/2005 sets the maximum quantities of pesticide residues permitted in products of animal or vegetable origin intended for human or animal consumption. These MRLs, which are fixed by the European Commission, include:

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

KEY POINTS

The MRLs for all crops and pesticides are listed in the Commission’s EU pesticides database.

Foodstuffs covered

The regulation covers all products intended for human or animal consumption, listed in its Annex I.

The regulation does not apply to products of animal or plant origin, if they are intended for:

• the manufacture of non-food/feed products;
• sowing or planting;
• nationally authorised tests on active substances.

Exceptions

Certain substances listed by the Commission (Annex VII) may be authorised by national authorities even if they exceed their MRL, if they meet the following conditions:

• the products are not intended for immediate consumption;
• controls are in place to ensure that these products are not made available to the consumer;
• the other EU Member States and the Commission are informed of the measures.

Safety assessment

The European Food Safety Authority (EFSA) is responsible for the safety assessment of new applications submitted for MRLs and for the review of existing MRLs. This is based on the toxicity of each substance, the maximum levels expected in food and the diets of consumers. Based on the EFSA’s opinion, the Commission issues a regulation to establish a new MRL or to amend or delete an existing one.

Controls of pesticides residues in food

The EU has a coordinated multiannual control programme which, each year, requires the Member States to sample, analyse and test an agreed range of products (relevant in the diet) for an agreed range of pesticides. This is to ensure their compliance with MRLs of pesticides and to assess the exposure to consumers. The EFSA collates these results and publishes them annually. Besides the coordinated EU programme, Member States have their own risk-based national programmes.

FROM WHEN DOES THE REGULATION APPLY?

The regulation entered into force on 5 April 2005 and became fully applicable in September 2008.

BACKGROUND

For more information, see:

• Maximum residue levels (European Commission)
• Pesticides (European Food Safety Authority).

MAIN DOCUMENT

Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16).

Successive amendments to Regulation (EC) No 396/2005 have been incorporated into the original document. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Commission Implementing Regulation (EU) 2020/585 of 27 April 2020 concerning a coordinated multiannual control programme of the Union for 2021, 2022 and 2023 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (OJ L 135, 29.4.2020, pp. 1–12).

See consolidated version.