Product safety for tissue products: the European perspective

Product safety is about customer health and safety including both skin and food contact.

In Europe there are a number of legislations and recommendations that can/shall be considered when manufacturing and selling tissue. This article will give an overview of European product safety demands. The content of this article is based on a lecture given at the Tissue Course at Karlstad University.

Charlotte Walldal, Karlstad Tissue University

LEGISLATION ON FOOD CONTACT. In the EU, all products intended for consumer usage have to comply with the Directive on general product safety. The aim is to protect the safety and health of the consumer. If there are no other specific demands on the product category, the general product safety directive applies.

Food contact materials are regulated by the so-called Framework Regulation 1935/2004 which applies for materials that are intended to be brought into food contact (ex. packaging) and materials that can reasonably be expected to be brought into contact with food (like tissue that is mainly used for cleaning and absorption). In this later category, tissue products like kitchen towels, napkins and wipes used in a food environment are included.

For food contact paper materials no specific EU legislation exists today. Instead, a Policy Statement for tissue kitchen towels and napkins (called “Tissue Guideline”) has been adopted by the Council of Europe. The “Tissue Guideline” is a guidance document for compliance with the Framework Regulation, given the consideration that the tissue end-user exposure is low. This assumes that tissue is only occasionally used in contact with food, and when it occurs it is only for a short time. There is also no significant migration of substances from the tissue into the food, as the main purpose of tissue is absorption. The “Tissue Guideline” is not mandatory and therefore not legally binding, but it can be used as a reference document by those countries that do not have a national legislation for paper.

Some European countries have a national legislation that regulates paper for food contact, including tissue. For example, France has the so called “French GMP” (Good Manufacturing Practices), in the Netherlands it is called the Warenwet and in Germany it is the BfR (Bundesinstitut für Risikobewertung) Recommendation 36. Many countries without specific legislation for paper refer to the BfR Recommendation 36.

LEGISLATION ON SKIN CONTACT. Skin safety shall be considered for tissue that comes into direct contact with the body, so-called sanitary paper. Examples are handkerchiefs, facials, toilet paper and the like. These products are not intended for food contact and therefore food contact legislation does not apply. There is no European legislation or recommendation for sanitary papers. In Germany, the BfR has published “Guidelines for Evaluating Sanitary Papers”. Sanitary papers are commodities and must be suitable for their intended use, i.e., they shall not endanger human health. The guidelines include a list of raw materials and a number of criteria for the finished product (limit values and test methods).

A special case of sanitary paper is tissue with added lotion or scent. The liquid added to the tissue must then comply with the EU Directive 76/768/EEC on cosmetic products.

The directive requires a product safety assessment which includes:

• Toxicological profile of the ingredients

• Restrictions for certain ingredients

• Exposure of the consumer

• Stability of the product

• Tests of skin effects and toxic effects

The production of sanitary paper with an added cosmetic substance should also follow the principles of GMP (Good Manufacturing Practice), see below.

THREE PRINCIPLES TO ENSURE PRODUCT SAFETY. In order to ensure the safety of tissue paper for the consumer, the following areas must be controlled:

• raw materials used

• manufacturing process

• quality of the finished product

These aspects are basic elements of product safety. Appropriate controls, tests and measures should be carried out. The demands can differ between legislations, but the principles are similar, therefore a general overview will be given.

RAW MATERIALS. For chemicals, there is typically a positive list of functional additives and process chemicals. There are also restrictions for substances not to be used, like the CMRs (carcinogenic, mutagenic or toxic for reproduction) or certain ingredients in colours and printing inks.

As fibrous raw material, both natural and synthetic cellulose fibres, wood pulp and certain fibres of synthetic high polymers can be used. Only certain grades of recovered fibres are allowed for usage. The use of recovered fibres requires an appropriate process treatment and tests of impurities in the finished product related to the grade of recovered paper used.

MANUFACTURING PROCESS. The manufacturing should be made according to GMP (good manufacturing practice). Good manufacturing practice is based on the principles of relevant quality management systems, such as the ISO 9000 series. It is also based on the relevant principles of a risk management system, such as HACCP (Hazard Analysis Critical Control Points).

A very important part of GMP is documenting every aspect of the process, activities and operations to demonstrate that the process is well under control. The management system covers every stage of production, including the procurement of raw materials, the different steps of processing, manufacturing and testing, finishing, and shipping of the product. An appropriate level of cleanliness, in terms of “good housekeeping”, has to be maintained throughout the whole process.

All finished products should be labelled so that relevant data of the production history can be traced. Traceability of finished products and raw materials enables an efficient recall procedure within a tissue mill and along the supply chain. It is therefore a fundamental tool to ensure consumers’ safety.

The HACCP programs began as extensions of the GMP. HACCP is a risk management system that is used in many industries with high demands on hygiene. HACCP is a tool for the identification, estimation and control of risks with regard to product safety. HACCP starts with an analysis of the food safety hazards which can be of biological, chemical, or physical nature. A risk assessment of the hazard is made looking at probability and severity. From that, the critical control points (CCP) are identified.

A CCP is a step at which control can be applied. It is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. A critical limit for the hazard is determined and routines are defined to ensure that the process is controlled at any time. An example of a CCP is the contamination of metal objects in the product. Means of control can be a metal detector at the packaging line.

The paper industry has invented the concept with CP (control point), which is used in parallel to CCP. The reason is that very few CCPs are found in the paper industry due to the low risk level.

The diagram on the right shows that the hazard analysis should cover the complete production process, including all stages.

Examples of possible risks are:

• chemical: wrong addition of chemicals, oil leakage, condensation drips;

• physical: glass breaking, foreign bodies;

• microbiological: personal hygiene, animals (birds, rats etc.)

Means of prevention can include: over-instructions (grade or product change), good housekeeping rules, proper training, cleaning instructions, personal hygiene instructions, maintenance instructions and separate work areas (production, storage).

The paper industry has started to get their mills certified. SCA have now a number of mills that are certified by an external body as meeting the requirements of HACCP Codex Alimentarius and Policy Statement concerning Tissue Paper Kitchen Towels and Napkins.

FINISHED PRODUCTS. In Art. 3 of the Framework Regulation 1935/2004 for all food contact material, it is stated that finished products shall not transfer their constituents to food in quantities which could:

(a) endanger human health;

(b) bring about an unacceptable change in the composition of the foodstuffs;

(c) bring about a deterioration in the organoleptic characteristics thereof.

In order to verify compliance with these demands, testing procedures and limits have been defined for the finished product.

• Heavy metals (cadmium, lead, mercury)

• Formaldehyde (from wet strong agents, retention aids, coating);

• Glyoxal (from coating);

• PCP (pentachlorophenol, can be formed during pulp bleaching;

• No transfer of antimicrobic constituents;

• DCP/3-MCPD (from wet strength agents);

• Printing inks/colours (no migration);

• Suitable microbiological quality.

When recovered paper is used as raw material, there are some additional substances that have to be tested:

• Phthalates (plasticisers, from offset printing inks or adhesives);

• Primary aromatic amines (from azo dyes);

• Optical brightners (no migration);

• Diisopropylnaphthalene (DIPN) (solvent from carbonless copy papers).

For the chemical substances testing methods and limit, values are defined. But for the demand on “suitable microbiological quality” the interpretation is not straightforward. The French GMP asks for test of pathogenic microorganisms, however, no guidance values are given.

In general, the microbiological quality of tissue paper is good. The total count of bacteria is usually very low and moulds are often not detected. Occasionally low numbers of sporeforming bacteria (Bacillus or Clostridia) are found. But also these values are normally not critical, as the migration of microorganisms from the tissue into food is negligible.

During the preparation for the certification of HACCP and Tissue Guideline at one of the SCA mills, a lot of work was put into the verification of the chemical and biological quality of the tissue. Investigations were made that demonstrate the efficiency of the deinking process in removing chemical substances. For example, substances like DIPN and phthalates were reduced substantially (almost eliminated) in the deinking line. The microbiological quality of the finished tissue was regularly tested and was found to be very low, often below the detection limit. A large comparative study between tissue made from virgin and from recovered fibres, including 6 mills, showed that, with a good deinking process the microbiological quality was very good and independent of the type of fibres used (virgin or recovered). •

For questions about the Tissue course at Karlstad University where product safety is on the schedule please contact Holger Hollmark (holgholl@kau.se).•

Login or Register to publish a comment