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European Food Safety Authority (EFSA) — ensuring safe food and animal feed in the European Union

European Food Safety Authority (EFSA) – ensuring safe food and animal feed in the European Union

SUMMARY OF:

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

WHAT IS THE AIM OF THE REGULATION?

  • Regulation (EC) No 178/2002 (the General Food Law Regulation) strengthens the rules on the safety of food and feed in the European Union (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 farms for private use or the handling of food at home.

KEY POINTS

  • 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 and any substance intended to be incorporated into food or feed 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 Member States in all areas that have an impact on food safety. It is also responsible for coordinating risk assessments, identifying emerging risks and advising on crisis management.
  • EFSA cooperates with the competent bodies in the Member States that carry out similar tasks to those of the authority and with other scientific bodies established under EU law, in particular the European Chemicals Agency (ECHA), the European Medicines Agency (EMA) and the European Environment Agency (EEA) on:
    • the provision of relevant scientific opinions;
    • the exchange of data and information, including the potential establishment of related data formats and controlled vocabularies to facilitate such an exchange;
    • the development of scientific methodologies for the assessment of chemicals.
  • Where risk is identified following a health risk analysis, Member States 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 Member States, the Commission and EFSA, enables information sharing on:
    • measures to restrict the circulation of food or on 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. Member States may take similar measures if the Commission fails to take action.
  • Together with EFSA and the Member States, 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 (e.g. 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 mainly amends 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 EFSA, such as 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 will 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, during the pre-submission phase, of all studies commissioned with a view to a future application procedure. This will guarantee that companies applying for authorisations submit all the relevant information and do not withhold 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. Member States, civil society and the European Parliament will be involved in the governance of EFSA by being duly represented in its management board. Member States will encourage the development of EFSA’s scientific capacity, 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.

FROM WHEN DOES THE REGULATION APPLY?

Regulation (EC) No 178/2002 has applied since .

The new rules contained in amending Regulation (EU) 2019/1381 have applied since .

BACKGROUND

Regulation (EU) 2019/1381 also amends another eight sectoral acts (i.e. acts on specific related sectors), as far as transparency aspects are concerned:

For more information, see:

MAIN DOCUMENT

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 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, , pp. 1–24).

Successive amendments to Regulation (EC) No 178/2002 have been incorporated into the original text. This consolidated version is of documentary value only.

Regulation (EU) 2019/1381 of the European Parliament and of the Council of 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, , pp. 1–28).

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