European Food Safety Authority (EFSA)
— ensuring safe food and animal feed in the EU
Regulation (EC) No 178/2002 — general principles and requirements of food law, establishing the European Food Safety Authority and procedures for food safety
Regulation (EU) 2019/1381 — transparency and sustainability of the EU risk assessment in the food chain
Known as the regulation on general food law, it strengthens the rules on the safety of food and feed in the EU.
It also sets up the European Food Safety Authority (EFSA), which provides support for the scientific testing and evaluation of food and feed.
The regulation does not cover production on the farm for private use or the handling of food at home.
Regulation (EC) No 178/2002 has applied since 21 February 2002.
No foods dangerous to health or unfit for consumption may be put on sale. The following factors are taken into account:
the normal conditions under which food is used by the consumer;
information provided to the consumer;
the effect on health, in the short and long term;
cumulative toxic effects;
the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers.
If any unsafe food or feed is part of a batch, it is assumed that the whole batch is unsafe.
Food legislation applies at all stages of the food chain, from production, processing, transport and distribution to supply. In particular, food businesses must:
guarantee the traceability of food, feed and food-producing animals at all stages of production and distribution,
immediately withdraw food or feed from the market, or recall products already supplied, if these are considered to be harmful to health,
inform the appropriate authorities, and consumers where necessary.
EFSA provides scientific and technical support to the European Commission and EU countries in all areas impacting on food safety. It is also responsible for coordinating risk assessments, identifying emerging risks and advising on crisis management.
Where risk is identified following a health risk analysis, EU countries and the Commission may adopt provisional precautionary measures consistent with a high level of health protection.
The rapid alert system for food and feed (RASFF) involving EU countries, the Commission and EFSA, provides for information sharing on:
measures to restrict the circulation of food, or its withdrawal from the market;
action taken to prevent, limit or impose specific conditions on the placing on the market or the eventual use of food or feed;
the rejection of a batch of imported food.
This information must also be made available to the general public where appropriate.
Where food or feed presents a serious and uncontainable risk to health or the environment, the Commission’s emergency protective measures can include suspending trade in or imports of the product. EU countries may take similar measures if the Commission fails to take action.
Together with EFSA and EU countries, the Commission must draw up a general crisis-management plan to cover situations where the standard emergency protective measures are insufficient. Where such a case is identified the Commission must immediately set up a crisis unit to identify the options for protecting human health.
The EU also aims to protect consumers against fraudulent or deceptive practices in the food trade, such as food adulteration (for example, horsemeat in beef products), and provide a basis for consumers to make informed choices about food.
Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain amends mainly Regulation (EC) No 178/2002. It seeks to do the following.
Ensure more transparency: The public will have automatic access to all studies and information submitted in support of any request addressed to the EFSA, e.g. to all studies supporting a request for an authorisation by a food business operator, early on in the risk assessment process. Duly justified confidential information will not be disclosed. Stakeholders and the general public will also be consulted on these submitted studies. The feedback received with allow EFSA to have access to the widest evidence base possible before it delivers its scientific advice.
Increase the independence and robustness of submitted scientific studies: EFSA will be notified of all studies, when these are commissioned, with a view to a future application procedure, during the pre-submission phase. This will guarantee that companies applying for authorisations submit all relevant information and do not hold back unfavourable studies. EFSA will also provide general advice to applicants, in particular small and medium-sized enterprises, prior to the submission of the dossier. The Commission may ask EFSA to commission additional studies for verification purposes in exceptional circumstances of serious controversies or conflicting results. The Commission will also perform fact-finding missions to verify the compliance of laboratories with the applicable standards for carrying out studies submitted to EFSA. The outcome of the fact-finding missions will be presented in an overview report.
Strengthen governance and scientific cooperation: EU countries, civil society and the European Parliament will be involved in the governance of EFSA by being duly represented in its management board. EU countries will encourage EFSA’s scientific capacity to develop, for example, by means of joint projects and the sharing of best practices, and will undertake promotion activities to ensure the recruitment of the best independent experts in EFSA’s work.
Develop comprehensive risk communication: a general plan for risk communication will be adopted by means of an implementing act to ensure a comprehensive risk communication framework throughout the risk-analysis process, combined with open dialogue amongst all interested parties.
The new rules contained in amending Regulation (EU) 2019/1381 apply as of 27 March 2021.
Regulation (EU) 2019/1381 also amends another 8 sectoral acts (i.e. acts on specific related sectors), as far as transparency aspects are concerned:
Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms,
Regulation (EC) No 1829/2003 on genetically modified food and feed,
Regulation (EC) No 1831/2003 on feed additives,
Regulation (EC) No 2065/2003 on smoke flavourings,
Regulation (EC) No 1935/2004 on food contact materials,
Regulation (EC) No 1331/2008 on the common authorisation procedure for food additives, food enzymes and food flavourings,
Regulation (EC) No 1107/2009 on plant protection products and
Regulation (EU) No 2015/2283 on novel foods.
For more information, see:
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 (OJ L 31, 1.2.2002, pp. 1-24)
Successive amendments to Regulation (EC) No 178/2002 have been incorporated into the original document. This consolidated version is of documentary value only.
Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (OJ L 231, 6.9.2019, pp. 1-28)
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, pp. 1-175)
Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, pp. 1-22)
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, pp. 1-50)
Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, pp. 1-6)
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, pp. 4-17)
Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, pp. 29-43)
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, pp. 1-23)