The declaration of compliance is an inherent part of a specific object or material destined for contact with food, but also reveals a lot about the company which produces it or puts it on the market. Europe has issued clear rules in relation to this; however not all materials are equally regulated at EU level and paper is one of those still waiting to be standardised.
The Declaration of compliance (DoC) has the task of certifying that a given product conforms to the use for which it has been made. It is a document which identifies, therefore, the purpose of the product itself and which, at the same time, serves as an indicator of the effectiveness of a company’s Quality Assurance System (QAS). A true company identity card.
An important document for so-called FCM – Food contact materials – in which every player within the chain is obliged, in addition to declaring its suitability for food contact, to report any modifications made to its product, which affect its composition, structure and function. In particular, the declaration of compliance must be supplied with full supporting documentation, which can demonstrate such modifications and specify any limitations or extensions of use of the product following on from these changes. Without the supporting documentation the DoC cannot be described as full and comprehensive. A sensitive issue, therefore, which from the heart of Europe rolls over to the various Member States.
The framework regulation governing the subject has been issued at European level. 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.The regulation contains articles reporting the most important recommendations in respect of products in contact with food and the general requirements needed in order to comply with EU legislation.
“In particular, article 3 is relevant”, explains Giacomo Belluomini, business technical spokesman for FCM at Ecol Studio, speaking on this matter at the Aticelca 2018 congress. “The article makes three very important points: the fact that the packaging which will be in contact with the food must not endanger health, or change the composition of the product with which it is in contact, or spoil its organoleptic characteristics. On the basis of these three principles, each company will develop analyses and checks to be carried out on the product depending on its own risk assessments and knowledge of its own manufacturing cycle”.
On the issue of DoC, it is clearly explained in Art. 16 of Reg. 1935/04, which presents two key points: “the first specifies how materials and objects which adopt specific measures, with standardised legislation throughout Europe, must be accompanied by a written declaration of compliance attesting their compliance. The second point states that, if there are no specific measures, the regulations do not prevent member states from maintaining in force, and consequently adopting, their own national provisions”.
The DoC for paper
Another focal point is Annex I of the European regulation. Materials adopting specific measures are listed, explains Belluomini. “From a list of seventeen materials, to date only four of these meet specific measures and are therefore standardised”, in particular they are active and intelligent materials, ceramics, plastic materials and regenerated cellulose.
“For paper and cardboard this has not yet happened”. Therefore, having no standardised European legislation, with regard to paper products each State must adopt its own national provisions. This often concerns companies in this sector who wonder whether or not to complete a DoC for food contact products.
To clear up any doubts in Italy, there is a decree to which the sector has referred for more than forty years, Ministerial Decree 21/3/73 which, in articles 6 and 7, addresses the issue of the declaration of compliance. Specifically, “article 7 states that the company must be supplied with the DoC issued by the manufacturer and inherent to the product which will come into contact with food; whilst article 6 states that every batch must be accompanied by the declaration of compliance. “Every batch’”, specifies Belluomini, “means that companies which produce materials for contact with food must supply, from their factory, production batches accompanied each time by a DoC. For logistical reasons, an identifying number of the declaration is often inserted. This, therefore, makes it unambiguous and reference can be made to it in the transport documents which will be purely linked to the production batch leaving the company”.
From the DoC to supporting documents
Whatever the material is which is placed in contact with food, and whether or not it is standardised, how should the declaration of compliance be structured? And how should a company producing such material behave?
Belluomini explains how the DoC document must, of necessity, contain some obligatory elements. First of all its letterhead must be drafted and the following reported: “identity and address of the operator who produces, imports or places on the market the material which will come into contact with food; the date of issue, which stipulates the start of the DoC and thus establishes the validity period; the specific reference standards which are respected by the materials used; the type of material that the product is made from and a unique identification of the article to which it refers – for example, the term “paper” will not be sufficient, it will be necessary to describe the material in more detail -; any limits of use that could result from the analytical protocols carried out under prescribed conditions – which therefore indicate that the material is only partial compliant -; finally, stamp and signature of the person responsible for the declaration”.
In addition to these recommendations, the DoC must be completed with the evidence and supporting documentation of the declaration itself. The manufacturer of material which comes in contact with food must have available a whole series of documents, with the obligation to make them immediately available in the event that the competent authorities want to check them. “The supporting documentation must include: all the declarations of compliance and technical sheets issued upstream by the suppliers of the raw materials and ancillary materials – it is important to stress that the technical sheets do not replace the DoC, neither are they ‘per se’ sufficient to form it -; the standard reference to which it will declare itself compliant; the control analyses programme and the results of laboratory tests. These latter”, explains Belluomini, “can also be replaced by “worst case” calculations carried out to verify the characteristics of the materials, of their disposal and, in general, of the properties, confirming that the paper produced is suitable for food contact”.
Duration of the declaration
On the other hand, the frequency of issuing declarations of compliance is not indicated by any legislative text, stresses Belluomini. However, the frequency inherent in the updating of the declaration of performance of the tests for suitability for contact with food “must be defined by the parties and, anyway, stipulated whenever required”. That is necessary, in particular, “whenever there are significant changes in the composition and characteristics of the raw materials used, or in the event that there are significant changes to the manufacturing process or, obviously, to the legislative references in force”.
Another element which has to be taken into account concerns conditions which involve the loss of the declaration of compliance, “a DoC is valid under the conditional terms of context, time and place, which are explicitly mentioned or with reference to other documents accompanying the declaration. If the user makes use of an FCM outside such terms, the condition of compliance will cease”. This is why it is essential to clearly specify what the mandatory terms of the declaration are and, above all, to link them to experimental tests which can demonstrate that which is declared.
A question of responsibility
Lastly, there is one aspect on which Belluomini insists particularly, the matter of responsibility. “The DoC”, he states, “is not a simple piece of paper, but implies taking on responsibility on the part of the company, which markets its own product, which is to be in contact with food. That means that it must be drawn up correctly and, a very important aspect, must contain all the necessary information and be supported by all the supporting documentation, which is essential in order to be able to demonstrate to a monitoring or competent body the validity of the declaration itself. Finally, I would like to emphasise one last point: independently of the fact of whether the DoC is obligatory or not, it is advisable that all those involved in the FCM chain issue the declaration, in order to guarantee correct information throughout the whole manufacturing chain and thus ensure that the final consumer is protected.