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Safety of Consumer Products

A/2008, 04.03.2008

Background information for journalists

Beverage bottles, t-shirts, toys, toothpaste - consumers come into daily contact with a wealth of products. They must be safe and it is down to manufacturers to ensure they are safe. The department for the "Safety of Consumer Products" within the Federal Institute for Risk Assessment (BfR) makes a major contribution to ensuring that the health of consumers is not impaired through the proper or foreseeable improper use of these products. The Institute’s health assessments are the foundation for regulations or recommendations for industry and users. When assessing the ingredients of these products, two aspects are taken into account:  the toxicity of a substance and the exposure - the type and scale of consumer contact with the substance. The intake of a substance may be oral (through the mouth), dermal (through the skin), or inhalational (through the lungs). The National Reference Laboratory for Materials in Contact with Foods within BfR develops analytical methods for the control authorities of the federate states. It also supports the control authorities in their testing activities.

What do we mean by "consumer products"?
Consumer products are products that consumers come into direct contact with. The term “articles of daily use” includes, pursuant to §2 of the Food and Feed Code (LFGB), a wide range of products: for instance toys, clothing, cutlery, cleaning agents for the home and packaging for food. Cosmetics are consumer products, too.

What are the main consumer products that BfR concentrates on?
The Department for Product Safety primarily assesses substance risks which may arise from a wide range of materials and articles that come into contact with food. Packaging, bottles, cutlery or kitchen utensils may contain harmful substances that migrate to food and are then ingested along with that food. It also looks at the ingredients of materials and products. This mainly concerns textiles like clothing and bed linen, and cosmetics. Cosmetics are intended as care products for the body. They are not supposed to influence body functions and have no healing properties. Shower gels, shampoos, deodorants, toothpaste, lotions, skin creams and make-up items are all included in this group. Toys are likewise consumer products. As the consumer group, children, requires special protection and they put toys in their mouths, particularly strict provisions generally apply to the substance safety of these products. Tobacco and tobacco products are another product group whose substance safety is assessed by BfR. The assessment of the technical safety of appliances like telephones, hifi systems and hairdryers is not, by contrast, the responsibility of BfR.

Another important area of BfR’s work is the documentation of intoxications with chemicals. After all products may carry risks which consumers have no inkling of. BfR documents cases of intoxications and formulations of products in a poison information database. Intoxications caused by the ingredients of products can then be rapidly identified and treated correctly. BfR passes on the formulations for emergency advice to the poison information and treatment centres of the federal states so that intoxication cases can be correctly treated as fast as possible on the basis of the right formulation information.

Who is responsible for the safety of consumer products and who monitors this?
Consumer products must be safe: no risks to health may result from their proper use. Manufacturers are responsible for the safety of consumer products. In the case of imported products, the person who imports these products into or places them on the market in Germany is responsible. The official control authorities of the federal states for foods and consumer products monitor whether the manufacturers, importers or distributors fully assume their responsibility and whether their products are really safe.

Which legal framework conditions apply?
The safety of products on the European and national levels is regulated by a number of directives, regulations, ordinances and laws.

On the EU level these are mainly the following directives and regulations:

• Directive 2001/95/EC “Product Safety Directive”
• Directive 2002/72/EC “Plastics Directive”
• Regulation EC/1935/2004 “Framework Regulation on Food Contact Materials and Articles”
• Directive 76/768/EEC “Cosmetics Directive”
• Directive 76/769/EEC “Chemicals Directive”
• Directive 88/378/EEC “Toys Directive”
• Regulation 648/2004/EC on Detergents

Furthermore, in Germany the following laws and ordinances contribute to product safety:

• Act on the Restructuring of the Safety of Technical Tools and Consumer Products
• Ordinance on the Safety of Toys
• Food and Feed Code
• Cosmetics Ordinance
• Consumer Products Ordinance
• Chemicals Act
• Ban on Chemicals Ordinance

What is assessed at BfR?
The risk assessment of substances in consumer products is undertaken from two angles. The first concerns the toxicology of the substance, what health impact the substance may have. Is it for instance carcinogenic, mutagenic or embryotoxic?  Does it irritate the skin or is it sensitising?  But even a toxic substance may only constitute a risk for the health of humans if they actually come into contact with it. The second aspect of risk assessment, therefore, concerns exposure. This means the type and scale on which people come into contact with a substance under normal circumstances. Migration values have been established for numerous substances. In conjunction with proper use, these values ensure that the amount of a substance released from a product will not result in the consumer suffering any acute or long-term health impairment through contact with that product. Hence, when assessing the risk linked to a substance in a consumer product, the decisive factor is not the levels contained in the product but what amounts may be released during use. When assessing exposure the route of contact between the consumer and a substance released from the product is also relevant: via the skin (dermal), the mouth (oral), or the respiratory tract (inhalational).

Food contact materials
Aluminium foil, breakfast bags, beverage cartons, filling hoses or the non-stick finish of cooking utensils - all these materials and articles must be manufactured in such a way that the amounts of their components that migrate to the food under normal and foreseeable conditions of use do not jeopardise the health of consumers. To this end, BfR sets limit values and communicates them to the general public in its “Plastics Recommendations”. They reflect the current level of scientific knowledge and technology. Even if they are not legal norms, they do serve manufacturers and control authorities as an important and accepted orientation aid for establishing whether a food contact article complies with the statutory safety requirements. BfR assesses whether or not a substance constitutes a risk when the need for this assessment arises.

In the health assessment of consumer products made of plastics and other materials, BfR is supported by the “Interim Plastics Committee”. The Committee is composed of scientists from universities, federal state authorities, industry and also scientists appointed by consumer associations. It also advises BfR on the drawing up of recommendations and participation in work on EC Directives and Council of Europe resolutions for plastics and other polymers.

The National Reference Laboratory for Materials in Contact with Food within BfR supports the public authorities of the federal states responsible for monitoring consumer products. It makes analytical methods available to the official control laboratories. If no methods are available, they are developed and validated in the reference laboratory and then passed on to the control authorities.

Extensive information on the assessment of substances in food contact materials can be found in the background information for journalists A/2007, BfR, 27 April 2007. (http://www.bfr.bund.de/cd/9281)

Cosmetics
When you mention the term cosmetics, most consumers think about foundation, eye shadow and lipstick. However, the cosmetics group encompasses many different types of product. Shower gels, shampoos, soaps, body lotions, deodorants, skin creams, toothpaste, shaving mousse, hair colour and sun screens - these are all cosmetics in the legal sense. When assessing substances in cosmetics, too, it must be established what amount of a substance can be taken up by consumers from the respective cream or lotion. In the case of cosmetics we need to know not only how the substances behave on the skin and what reactions they trigger. It is equally important to know whether the substances can penetrate the skin and enter the body. One test method can use pig skin, which has a similar structure to human skin, to determine what amount of the substance can penetrate the skin and reach the blood circulation via the skin and what consequences this has for consumer health. This plays a role not only in cosmetics which remain (temporarily) on the skin for a specific time but also for instance in dyes for permanent make up and tattoo dyes. Although millions of people have tattoos and use permanent make up, we hardly know anything about how the dyes behave when they remain on and in the skin for a lifetime or reach the body through the skin.

BfR advises the Federal Ministry of Food, Agriculture and Consumer Protection on questions concerning the health assessment of cosmetics. This covers, for instance, technical questions relating to the amendment to the Cosmetics Ordinance and its annexes and monitoring issues. In this field the Institute enjoys the support of the Committee for Cosmetics (Cosmetics Committee). Scientists from universities, federal state authorities, industry as well as scientists nominated by consumer associations are appointed to the Committee. The results of the advisory activities of the Cosmetics Committee reflect the current level of scientific knowledge. Hence they are also the foundation for the decisions of the control authorities of the federal states.

Toys
Toys also contain a number of different chemical substances. Plasticisers make plastic toys flexible. Toys are painted or dyed with a diverse range of colours. Special varnishes protect wooden toys from damage. Depending on how strongly the chemical substances are bound to a product and the strain placed on that product, minute or larger amounts of the substances may be released. During play they may be taken up by children through their skin or through their mouths. Infants in particular have a habit of putting toys in their mouths and chewing on them. Hence they are particularly exposed to the substances contained in the toys. BfR advises the competent ministries on the review of the Toys Directive. Furthermore, BfR staff participate in the bodies which draw up standards for toy safety. More comprehensive information on toxicologically relevant substances in toys can be found (in german) in the BfR Opinion No. 030/2007 (http://www.bfr.bund.de/cm/216/migration_von_toxikologisch_relevanten_stoffen_aus_spielzeug.pdf)

Textiles
A whole series of chemicals are used in the production of textiles. They give the textiles the desired characteristics like colour, form, grip or a water-repellent finish. After production, residues of the chemicals sometimes remain on the textiles and are then released during wear. Hence, new textiles should be washed before they are worn for the first time. Within BfR general statements are elaborated about the hazard potential of substances in textiles (clothing) that come into contact with the skin. For instance the Centre for Experimental Research looks at artificial sweat preparations in order to determine which substances may be released from textiles during wear. The released mixture is toxicologically examined. In in vitro experiments with bacteria or cell cultures it can be tested whether the substances or substance mixtures harm human cells or the genotype. Other test methods simulate how the bacterial flora of human skin reacts to these released substances. Research work at BfR has revealed that certain azo dyes, which are not problematic initially, can be cleaved on the skin by bacteria into allergenic or even carcinogenic substances.

An overview of the assessments and recommendations is given in Information 018/2007. (http://www.bfr.bund.de/cm/230/introduction_to_the_problems_surrounding_garment_textiles.pdf)

Outlook:  New focal areas of work of the Product Safety Department
The BfR Product Safety Department currently has a staff of 32, including 17 scientists. In the course of the next few years the department is to grow in size. Henceforth, it is to focus more on research in order to close the major gaps in knowledge about the toxicity of and exposure to ingredients in consumer products. One focus will be research on allergies. By means of in vitro cell culture systems, the allergenic properties of chemical substances are to be examined and quantified. Exposure research will mainly concentrate on developing methods to analyse the behaviour of chemical substances on the skin and what happens when they penetrate the skin. Many questions are still unanswered concerning the action of chemical substances in the respiratory tract. Therefore, methods are to be elaborated to determine inhalational exposure.

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