Food safety and hygiene

The Firm offers advice and assistance in the legal framework of food safety and hygiene

  • Traceability

    According to Article 18 of Regulation (EC) No. 178/2002, all food business operators (FBOs)
    shall ensure traceability of food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution.

    To this end, such operators shall have in place systems and procedures which allow to:

    • To identify any person from whom they have been supplied (backward traceability)

    • To identify the other businesses to which their products have been supplied (forward traceability)

    • To make this information available to the competent Italian health authority on demand

  • Withdrawal and recall procedures

    According to Article 14 of Regulation (EC) No. 178/2002, FBOs shall not place on the market food that they consider not in compliance with the food safety requirements, that is if it is injurious to health or unfit for human consumption.

    If a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed 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.

    Where the product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient to achieve a high level of health protection.

  • Hygiene requirements

    As set forth in Article 4 of Regulation (EC) No. 852/2004, food business operators carrying out any stage of production, processing, distribution and storage of food shall comply with the general hygiene requirements.

    Such requirements, often referred to as “prerequisite programs” (PRPs), are practices and conditions needed prior to and during the implementation of HACCP and which are essential for food safety.

    PRPs can be divided into the following main categories:

    • General hygiene provisions listed in Annex I of Regulation (EC) No. 852/2004, to be applied to primary production (to all phases of production of primary products as well as rearing, hunting and fishing, including harvesting, milking, and livestock breeding prior to slaughtering)

    • General hygiene provisions listed in Annex II of Regulation (EC) No. 852/2004, to be applied to the activities carried out after primary production

    • Specific hygiene requirements for products of animal origin laid down in Annex III of Regulation (EC) No. 853/2004, regarding both primary production and subsequent activities

    Hygiene requirements also include proper training for operators handling food but also for the ones dealing with the drafting and implementation of HACCP protocols.


    Article 5 of Regulation (EC) No. 852/2004 establishes that food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles, which are:

    • Identifying any hazards that must be prevented, eliminated or reduced to acceptable levels

    • Identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels;

    • Establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards

    • Establishing and implementing effective monitoring procedures at critical control points

    • Establishing corrective actions when monitoring indicates that a critical control point is not under control

    • Establishing procedures, which shall be carried out regularly, to verify that the measures outlined above are working effectively

    • Establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined above

  • Flexibility

    Article 7 of Regulation (EC) No. 2074/2005 provides a simplified procedure through which Member States can grant derogations to the application of PRPs.

    Derogations can only be granted in the case of “foods with traditional characteristics”
    as regards the premises where they are made and the type of materials of which the instruments and the equipment used specifically for the preparation, packaging and wrapping of these products are made.

    Namely, such foods must be:

    • Recognized historically as traditional products or

    • Manufactured according to codified or registered technical references to the traditional process, or according to traditional production methods or

    • Protected as traditional food products by a Community, national, regional or local law

    As for HACCP-based systems, it is the same Regulation (EC) No. 852/2004 that allows a “flexible” application of the procedures based on such system, taking into account both the characteristics of the activities carried out by FBOs and the size of the company. More information on this topic are to be found in Commission Notice No. 2016/C 278/01.

Services provided by the firm

The Firm offers its support to operators willing to:

  • Defining procedures for product traceability

  • Complying with food hygiene requirements

  • Assessing compliance with legal obligations on the implementation of HACCP principles

  • Dealing with mandatory training on the implementation of HACCP principles

  • Granting flexibility and derogations to hygiene requirements

  • Implementing withdrawal and recall procedures for hazardous products

Contact us for more information or fill out the FORM to get an estimate of costs for our services

Altri Servizi

Labelling and information for consumers

Mandatory information, voluntary information, nutritional and health claims.


Production and commerce, labelling, PDO and PGI, registers and declarations, aromatized wines.

Food supplements, fortified food and novel food

Food supplements, fortified food, novel food, food for specific population groups.

Geographical indications and quality schemes

PDO, PGI, TSG, organic, integrated production, certification and collective marks.

Organization of the company and trade relations

Contracts, e-commerce, trademarks, penalties, debts recovery, litigations.


Obligations to start production, public contribution, administrative proceedings and appeals.

Training and corporate advice

On-premise training courses, webinar, ongoing legal advice.