Spotlight: food and cosmetic safety in Spain

Spotlight: food and cosmetic safety in Spain

All questions

Food and cosmetic safety

i Regulatory framework

The main regulatory body governing the Spanish food and beverage industry is the Spanish Agency for Food Safety and Nutrition (AESAN).14 One of AESAN’s main objectives is ensuring the safety of food products and beverages. AESAN is responsible for coordinating regulatory compliance control and the development of strategies to boost education and health information in the field of nutrition. In line with these functions, it offers useful information to consumers through its informative database to protect their interests.15

In turn, regulatory compliance control is highly decentralised and, as such, each autonomous region has its own agency entrusted with these matters; the agency is normally the corresponding public health department.

The lead regulatory body in the cosmetics industry is the Spanish Agency of Medicines and Health Products (AEMPS).16 AEMPS systematically collects, evaluates and monitors information on the undesirable effects observed as a result of the use of cosmetics (denominated ‘cosmetovigilance’). In Spain, cosmetovigilance activities are organised through a notification system. Regional agencies also have competences in the field.

ii Food additives and contaminants

Spain’s regulatory framework on food additives and contaminants is based on EU standards. Regulation 1331/2008 establishes a common authorisation procedure for food additives,17 and Regulation 1333/2008 lays down rules to achieve a high level of consumer protection and safeguarding of human health.18 In order to make the corresponding rules more accessible to consumers, AESAN produces an array of resources aimed at consumers (e.g., guides, short reports and databases). Examples of these include the Guide on the Description of Food Categories in the Additives Regulation and the Guide to the European Authorisation Procedure.

EU Regulation 315/93 sets out the framework governing matters involving food contaminants.19 The general rule is to ensure that contaminant levels are as low as reasonably possible. To do so, Regulation 1881/2006 sets maximum levels for specific contaminants.20 The overarching objective is to protect public health and ensure that good manufacturing practices regulations are being followed, recognising that contaminants might enter food at any point from production to consumption.

iii Recalls

Pursuant to EU Regulation 178/200221 and Spanish Law 17/2011, both food and food business operators that believe, or have reasons to believe, that a food that it has imported, produced, processed, manufactured or distributed does not comply with food safety requirements or, in particular, appears to be unsafe must immediately communicate to the corresponding authorities the specific risk of the food product and commence any procedures or corrective actions to mitigate that risk, including the withdrawal of the food in question from the market on which the food has left the immediate control of that initial food business operator and inform the corresponding authorities thereof. If the product has reached consumers, the operator must effectively and accurately inform consumers of the reason for its withdrawal and, if necessary, recall products already made available to consumers when other measures are insufficient to achieve a high level of health protection.

In other words, operators must notify the corresponding authority of the existence of the risk and take adequate corrective measures to avoid or mitigate the risk. Among these corrective measures, which are mandatory at both domestic and European levels, the implementation of traceability systems is a basic risk management tool that increases efficiency of internal management in terms of the level of information available on products and processes, which undoubtedly contributes to increasing consumer confidence.

The guidance on the implementation of Articles 11, 12, 14, 17, 18, 19 and 20 of Regulation 178/2002 on the general food law conclusions of the standing committee on the food chain and animal health, approved on 26 January 2010, provides various guidelines in this regard.22

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