One of RepaQ’s functions is making sure that our partners comply with the regulation relative to food contact materials (EUROPE (EC) Regulation 1935 of 2004). Knowing the graphic that you will find in this post is a key to implement this function. Hereunder, we will proceed to spell out the header of the chart. In other words, we will expose the horizontal application regulations that enclose the specific legislation per food contact material type and the specific legislation on limitations on presence of substances on food contact materials. Get comfortable and let us get to the point!
To guarantee that the organoleptic characteristics and the food security are not modified by molecules transferred to it and with the need to align specific practices with the food industry, were written the Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food and the Regulation (EC) No 2023/2006, on good manufacturing practice for these materials and articles.
As can be observed in the scheme, the Regulation (EC) 1935/2004 leads the regulatory framework of food contact materials and applies to any material or article intended to come into contact with food. A list of materials which are or could be covered by specific measures or regulations is given in the annex I. The materials highlighted in bold have already specific regulations (we will talk about it in other post):
For those materials which do not have yet a specific measure at European level, in the article 6 of the regulation is indicated that the Member States can adopt national provisions provided they comply with the rules of the Treaty. Countries such as Holland, Italy, France and Germany created a national legislation for articles and materials of paper and paperboard intended to come into contact with food. Accordingly, the paper and paperboard suppliers which provide these countries, not only must be governed by the Regulation 1935/2004 but also by the national provisions. Notable is the German BfR Recommendation XXXVI on paper and board for food contact, followed by many countries that do not have any national provision on these materials. Another example of materials without a specific measure at European level are the printing inks over food packaging. Switzerland included on the Ordinance of the FDHA on food contact materials and articles (SR 817.023.21) specific measures applicable to the inks to ensure that a printed material is safe for food use. In this ordinance are presented two positive lists of substances for the inks production in several annexes, one of this lists was initially compiled by EuPIA (European Printing Ink Association).
The group of materials and articles -contained in annex I and previously listed- and its combinations, including the recycled materials and articles, should be manufactured in compliance with general and detailed rules on good manufacturing practice (GMP).
The Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food emphasizes the need that all business operators implement an effective quality management of their manufacturing operations which should be adapted to their position in the supply chain. This regulation applies to all sectors and to all stages of manufacture, processing and distribution of materials and articles, but excludes the production of starting substances, of which will be only selected for the production those which comply pre-established specifications. The regulation exposes the general laws on the GMP, such as the establishment of quality assurance system and quality control in addition to the appropriate documentation for these systems. Single annex exposes detailed rules on good manufacturing practice for processes involving the application of printing inks to the non-food contact side of a material or article and it finalizes indicating that printed surfaces shall not come into direct contact with food. In order to comply with the regulation on GMP, the business operator shall establish, implement and ensure adherence to an effective and documented quality assurance system taking account of the adequacy, knowledge and skills of personnel, the organization of the premises and equipment and, lastly, the size of the business, to prevent imposing an excessive burden for its capacity. The documentation in paper or electronic format shall be established and maintained by the business operator and this documentation shall cover the specifications, manufacturing formulae and processing which are relevant to compliance and safety of the finished material or article. The documentation shall be made available by the business operator to the competent authorities at their request.
In future posts we will go farther into specific measures that complete the scheme skeleton.
Do not hesitate to contact RepaQ for deeper analysis on these regulations. Not only we can analyze that your industry is in compliance with the legislation, but we can also offer courses so that you will easily interpret its content and will be able to extrapolate it to your business area.