Regulation 178/2002 outlines the general principles of food law. Article 18 requires that from the 1 st of January 2005 all food businesses must have in place a traceability system. The regulation is minimal in its description of what is required and it would in no way reflect what is considered to be best practice. The legal minimum is a system in which a food business records what ingredients / food products it receives and from who (inc. contact details) together with what product it dispatches to which customers (inc. their details) with the only exception being direct supply to final consumers. This is called the one-up-one-down system. Traceability information must be transferred up/down the chain on the product or on accompanying documents.
Q. Will the FSAI be providing any further guidelines on how to meet the requirements of Regulation 178/2002?
No. The FSAI does not have any plans to introduce further guidelines. Guidance Note No. 10 (GN 10) is a best practice document and goes beyond the minimum legal requirements. However, the FSAI will need to provide guidance to official agencies in Ireland on compliance when an enabling Statutory Instrument (S.I.) is put into Irish legislation.
Q. Is any indication given of how long a business should keep traceability records?
Other countries such as Belgium and Netherlands have indicated exactly how long the records should be kept, but Ireland has not gone into this detail. The proposal on the table in the European guidance discussions is a minimum of 5 years, with exceptions for short shelf life products being provided directly to consumers. If this is adopted then Ireland will also insist on this as a minimum period . In addition traceability records should also be made available on request by inspection/enforcement officers regardless of where they are physically stored by a business.
Q. Does the legislation require food businesses to be able to trace what customer received what batch of product?
To comply with the legislation you only need to know that a certain product went to a certain customer(s). It is not necessary in law to trace to the batch level. A minimum would require a list of ingredients and their respective suppliers and contact details together with a list of what products went to which customers including their contact details. This may change following European guidance but is a reflection of the current state of play. However, adhering only to the minimum legislative requirements may carry a high financial risk and may result in your customers taking their business elsewhere as your limited system leaves them exposed to possible recalls (See Q.4). To limit your business liability best practice is to be able to say which batches and the quantity of which product went to which customer.
Q. A food business can trace all products distributed at a product level (i.e. any product we distribute, we know who supplied us with it and we know what customer we sold it to). However, currently it cannot trace to supplier lot/batch code level. Is this system compliant or non-compliant with Regulation 178/2002?
By 1st Jan 2005 the minimum requirement in law is to have a system that records what foods came from what suppliers and what customers received what foods from the company. This information must be available on demand to the authorities. The bare minimum would be to know that supplier "A" supplied ingredient named "X" and that product named "Y" was sent to customer B. If you can't trace lot numbers then in the event of a recall all product with that name would have to be recalled. This is a business liability issue (See Q.3). Not having a full lot/batch tracing system would not be a defense for not having a minimally complying system even if this latter system were temporary.
Q. How do you track bulk materials such as water or milk used in production?
In the case of bulk materials, it is necessary to time and date stamp when the product was used. If using silos etc., keep records of when new product was added and when quality assurance/control tests were carried out on the product. Manufacturers of foodstuffs delivered in bulk may only be able to define a product batch within a defined time frame such as a day's production. Other manufacturers or caterers may be able to define a batch as an individual saleable unit. The majority of food businesses will adopt an approach between these two extremes. A balance must be struck between the complexity and workability of a traceability system and the smallest feasible batch size. If a food business chooses the date of minimum durability ( i.e. shelf-life) as their batch code (where the legislation allows) then all of the specified product carrying that date must be recalled/withdrawn in the event of a food safety incident.
In addition in the case of bulk delivery of ingredients into bulk storage facilities, it may not be possible to ensure that only ingredients from one batch are present. The delivery dates, identification of storage facility and weight/volume of the delivery may be the only way of identifying an ingredient. In this event it is necessary that the contents of a bulk storage facility are traced through production. Remember that a real batch is one that is separated from another batch by a clean break. Batch codes that refer to batches that are not separated as such will not necessarily restrict the extent of a recall which will inevitably include related batches.
Q. With whom does the responsibility for traceability lie if you are using a 3 rd party logistics provider?
Who owns the goods is irrelevant. Regulation 178/2002 relates to food business operators and their responsibilities. Your 3 rd party logistics provider is a food business in their own right and therefore they must have a traceability system for the product they handle even if they don't own it. However, it would be recommended that a food business distributing food through a 3 rd party logistics provider works out some form of integrated system to speed up retrieval of records should a recall be necessary. After all it will be your product that is recalled and your business that will take the hit. If a logistic outfit is owned by the food business and is therefore not a separate food business the logistics operation should be included in the scope of the company's traceability system.
Q. Is it acceptable to scan product at the point of picking or loading rather than the point of delivery?
The site at which you record information is not specified in the legislation. However, if you have product or raw materials on the premises that you don't have tracked in your system then you will not be compliant with the law. The best place to record information is at the goods inwards area and at the point of dispatch.
Q.Have any studies been carried out on the cost implications of the new traceability regulations on Irish food businesses?
The simple reply is no - it is a European regulation and is binding on Ireland without room to derogate for small businesses. However, the regulation requirement is extremely simple and should impose only minimal costs on small businesses. However, costs increase as complexity increases but with increasing complexity comes increased business liability assurance. The choice of whether to implement a complex system will be a business decision based on customer requirements and business protection rather than legislative requirements.
Q. Where does the responsibility for product recall lie? A food business distributes products on behalf of other producers; if their product is contaminated but the food business had purchased the product from them, is the food business responsible for the cost of the recall or is the original supplier who contaminated the product?
The authorities have no interest in who is responsible for cost. As a distributor you are responsible for the safety of the food you distribute. If your business activity does not affect the packaging, labelling, safety or integrity of the food you must withdraw the product from sale within the limits of your activities (i.e. no more sale or distribution from your business or businesses within your sphere of influence). You must also notify the supplier of the problem and the authorities. The supplier will then be responsible for wider withdrawal and recall. This will be enforced by the authorities if they are reluctant. You are also obliged to co-operate in any recall/withdrawal activity and any official investigation. The bottom line is consumer protection NOT business protection
Q. Who should be contacted in the FSAI in the event of a product recall and how should they be contacted?
GN10 has a list of contacts - we would encourage food businesses to notify the enforcement officer in charge of the food business in the first instance and only the FSAI (Rapid Alerts Team: 01 8171378) in the event that you cannot contact them.
Q. If a food business (e.g. retail multiple) operates their own central distribution centre (CDC) and they then supply their own individual retail units from this CDC what level of traceability is required and were does the responsibility for ensuring traceability lie?
In article 18 the requirement to be able to trace food is the responsibility of the food business operator. The food business operator is defined in 178/2002 as:
3. 'food business operator' means the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control;
The food business under their control is defined in 178/2002 as an undertaking rather than single premises:
2. 'food business' means any undertaking, whether for profit or not and whether public r private, carrying out any of the activities related to any stage of production, processing and distribution of food;
Therefore the owner or CEO or head person of a retail multiple is responsible for ensuring traceability in their CDC's and stores as a single business. Hence the CDC must be capable of identifying what products are received from which suppliers and which customers receive what product but if the customers are other food businesses rather than the retailers own stores product transfers will have to be traced (this might apply for returns to suppliers).
As traceability does not extend to the final consumer the stores themselves are not required to trace product they sell and if they receive supplies only from the retailers own CDC then they don't need to have supplier traceability. Equally if returns from the stores only go to the CDC then they don't need to trace them but if they go directly to the original suppliers then the retail shops would have to have systems that track what product was returned to which supplier.
It is also worth noting that article 19 on recall requires that the retail business including the CDC has an adequate system to prevent the sale of unsafe food to consumers, a system that allows them to locate and remove unsafe products from sale and a system that allows them to participate in any recall or withdrawal initiated by a supplier of the competent authority. This latter requirement may mean the return of unsafe food to the supplier or its destruction depending on what they are asked to do. These considerations also need to be built into retailers systems. The above would not hold for symbol groups because the stores are not owned by the symbol group and are therefore separate food businesses. In this case the CDC would have to have a full supplier and customer traceability system and the individual stores would at least need a supplier traceability system.
In addition to the requirement to keep the traceability information, article 18 (2) also includes the requirement for "operators to have in place systems and procedures which allow for this information to be made available to the competent authorities" on demand. The traceability information should be retrievable at CDC or retail store level. Where the retail outlet is sourcing from both the CDC and direct suppliers, this information should be kept and be available at the store. The requirements should be read in conjunction with article 19 on Responsibilities relating to withdrawal and notifications to the competent authorities - the term 'on demand' in article 18 should be considered in the same terms as 'immediately' as used in article 19. This would be the provision of the 'basic' traceability information - as what from where. More detailed information such as batch or lot codes etc where available, would need to be provided without delay.
Q. Will regulation 178/2002 require individual containers/packages to carry information, e.g. in the form of a code, that would identify the retailer?
If the intention is to allow for a single container/package of product to be traced to the retailer from which it was sold then this level of traceability is not required by 178/2002.
Q. Will the traceability requirements apply to products/services imported from outside the EU?
Q. What will be the European and/or Irish National penalties for non-compliance with articles 18 and/or 19 of Regulation 178/2002?
The penalties have yet to be decided and will need to be set in Irish legislation by one of the Government Department s .
Q. A food business producing own branded product for supply to and sale by a retailer prints their business name and address on the packaging of the product. Does the inclusion of the business name and address on the packaging comply with the legislative requirements for product traceability?
The current labelling legislation allows the name of the seller to be printed on the packaging of the product. In the above case this would be the retailer. This practice is common with own brand products. The traceability legislation covered under Article 18 says that:
4. Food or feed which is placed on the market or is likely to be placed on the market in the Community shall be adequately labelled or identified to facilitate its traceability , through relevant documentation or information in accordance with the relevant requirements of more specific provisions.
Therefore, to comply with the legislation, the documentation that accompanies the product from the producer should contain the product name and identification (e.g. batch code) and the name and address of the food business that is supplying the product to the retailer. The retailer's traceability system would need to record that the product comes from this food business for their system to be compliant. There is no specific requirement that the food business producing the product should print their name and address on the product providing it is on the documentation accompanying the product.
Last reviewed: 13/10/2011