Labeling ‘nano’ products – ‘mega’ problem
From 11 July 2013, under EU cosmetic regulation 1223/2009, all ingredients present as nanomaterials have to be indicated on the package with the term ‘nano’ in brackets; ‘nano’ means: ‘an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm’.
This new cosmetic requirement is implemented as national law in 27 EU member states plus Norway, Iceland and Lichtenstein. The EU regulation 1223/2009 replaces the old cosmetic directive 76/68/EEC and the subsequent 67 amendments. According to the new regulation, there are three new requirements for industry: the labeling of ingredients that are nanomaterials; notification to the European Commission (EC) six months prior to placing the product on the market; and safety assessment of the cosmetic product with particular attention to nanomaterials.
The EU regulation 1223/2009 applies also to products which are already on the market. The EC will publish a catalogue of nanomaterials used in cosmetics, and annual status reports to the EP and Council.
Nanomaterials have been used in cosmetics for years. But until recently, the term ‘nanomaterial’ meant different things to different manufacturers and almost nothing to consumers. According to the EC, nanomaterial is a natural or manufactured active or non-active agent ‘containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm. Fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nano-materials’. A particle is considered to be ‘a minute piece of matter with defined physical boundaries’; agglomerates are ‘a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components’ and an aggregate ‘a particle comprising of strongly bound or fused particles’. It is interesting to notice, that this definition does not follow the recommendation for the definition of ‘nano’ for labels made by the EC, although they were issued simultaneously.
The number of consumer products on the market containing nanomaterials has been strongly increasing during the last years, however, very few of them carry specifically ‘nano’ label, except for promotional purposes. These products range from car wax, plastic products and self-cleaning surfaces to clothes, cosmetics, food or drinks. For instance, nanopigments such as titanium dioxide (TiO2) and zinc oxide (ZnO) are used primarily in sunscreens for their capacity to reflect and scatter UV light. Other nanoscale materials such as carbon fullerenes (also known as buckyballs) are used because of their antioxidative properties. According to market research by Mintel Group, the top ten claims associated with personal care products using nanotechnology are moisturising/hydrating properties (46%); botanical/herbal products with nanomaterials (45%); long lasting effects (28%); better nutrition through vitamin/mineral fortified products (28%); faster speed of effects (22%); anti-ageing (20%); antioxidant (20%); brightening/illuminating (18%); UV protection (17%); and enabling the avoidance of using additives/preservatives (13%).
As only labeled cosmetics are considered safe, nano-products may only be marketed provided that they are specified as such. The main reasons for the labeling obligation are to give unambiguous information that will allow consumers to make responsible purchasing choices, and secure, healthy and sustainable product development. Such obligations should also reconcile the diverging interests of consumers and industry. Labeling impacts depend largely upon what people associate with different products or technologies. Positive or negative associations will either increase or decrease the purchasing of nano-products. Informed and responsible purchasing decisions and secure product development require a transparent legal framework and uniform labeling obligations. In any case, labeling obligations create knowledge.
For several years now, environmental and consumer protection organizations in particular have called for the labeling of nano-products to enable consumers to make informed purchasing decisions. While voluntary initiatives can be regarded as having failed due to opposition from industry, and probably also a lack of demand from the consumers up until now, the coming years will see labeling of nano-products through provisions of EU law. From 11 July 2013, the manufacturer or the importer of the cosmetics is the one responsible for the labeling. Additionally, the distributor needs to verify the labeling information before placing the product on the market. Incorrect labeling may lead to a variety of consequences: conditions may be imposed upon the person responsible for labeling (manufacturer or importer). The person may be required to withdraw or recall incorrectly labeled cosmetics from the market.
Most of all, there are important questions that need to be answered: shall I be scared of the nano-ingredients? Does so small ‘nano’ really go through the skin making dangerous changes? If the skin is perfectly able to keep out water and glucose, so how much harder would it be for a particle as large as TiO2 to penetrate it? After all, a small particle of TiO2 is one million times larger than a glucose molecule, and 27 million times larger than a water molecule. It is known, that the skin is a very effective barrier-to worry about ‘the absorption’ of nanomaterial by the same skin that effectively prevents the entry of substances so much smaller would seem to be groundless. During the last years, researches have been trying to answer those questions. However, till now, there is no clear statement on that.
Additionally, on 25 October 2011, following several years of negotiations, upon the new provision of food information to consumers (Food Information Regulation), the EU proclaimed a requirement for labeling food products containing nanomaterials. Like the Cosmetics Regulation, the Food Information Regulation is directly applicable in all member states. In general its aims are to inform consumers and enable informed purchasing decisions. Labeling is to be effected in words and numbers, and pictograms and symbols may be used in addition; the information is to be written in a language which is easily comprehensible for the consumer. The labeling requirements address food business operators across the entire food chain. The Food Information to Consumers Regulation has been in force since 12 December 2011 and will be applicable from 13 December 2014 onwards.
Rene Röspel, German MP: ‘It’s difficult to decide for or against nano-labeling, because many questions need to be answered first. For example which nano definition do we want to use? Which size range do we choose for that and do we include natural particles as well? What should this labeling tell the consumer? Should consumers handle nano-products differently from standard ones? I don’t see these questions answered fully yet. Once we have the answers, then labeling more consumer products might be a good idea. Personally I would prefer a sunscreen without nanoparticles, but most sunscreens sold in Germany include them already.’
Richard Seeber, EU MP from Austria: ‘Nanotechnology is a powerful scientific field. Its advances can offer great opportunities for the EU’s growth, competitiveness and sustainable development. At the same time, nanomaterials may bear risks for consumers and workers. If cosmetics include nanomaterials, safety concerns must be paramount. Consumers should be informed of all product ingredients, including nanomaterials, in order to choose their products accordingly. I am therefore in favor of the labeling of nano-content in cosmetics and sunscreens. I personally will continue to use sunscreen containing nano-particles. Cosmetics manufacturers are prepared for the change in legislation and will have the opportunity to provide consumers with an even bigger variety.’
Maya Graf, Swiss MP: ’I clearly support the labeling of cosmetics and sunscreens containing nanomaterials. According to the Woodrow Wilson inventory on nanotechnology, 143 cosmetics products and 33 sunscreens currently on the market contain nanoparticles, so I suppose manufacturers will have to endeavor to evaluate safety and labeling standards. Similarly with the case of labeling of GM food products, I assume that nano-cosmetics labeling will slow down the business. In my opinion labeling is much important for food products containing nanomaterials, since several studies show that there is lack of safety information on various nanoparticles used in food. Personally I would not buy nano-sunscreens nor eat food containing nanomaterials.’
Vittorio Prodi, EU MP from Italy: ‘I am not against the nano-labeling of cosmetics and products containing nanomaterials in general. But it’s important that any label comes with a key to understand what it says: the possible risks, the appropriate behavior to minimize that risk – we also need more research on these issues. But a label with no explanations could unleash alarmed reactions in the population. Personally I don’t have problems using sunscreens with added nanoparticles, since there is no proven risk for the skin. Instead, I would be more careful with products or materials that free nanoparticles in the air, because they could easily get into contact with our lungs thin tissue, altering cellular functions.’
Bowman, DM, G van Calster and S Friedrichs (2010), ‘Nanomaterials and the regulation of Cosmetics’, Nature Nanotechnology, 5(2), 92.
EU regulation 1223/2009.
EU regulation 1169/2011.
EU recommendation 2011/696.
EU directive 2002/95/EC.
EU directive 2011/65/EU.