Biomedical Engineering Reference
In-Depth Information
No. 1223/2009 prohibits the use of substances recognized as carcinogenic, mutagenic, or toxic
for reproduction (classified as CMR), apart from exceptional cases. It provides for a high level of
protection of human health where nanomaterials are used in cosmetic products.
To improve consumer protection, containers or packaging must bear written information in
indelible, easily legible, and visible lettering. This information must include:
The name or registered name and the address of the responsible person
The country of origin for imported products
The weight or volume of the content at the time of packaging
A use-by date for products kept in appropriate conditions
Precautions for use, including for cosmetics for professional use
The batch number of manufacture or the reference for identifying the cosmetic product
The list of ingredients, that is, any substance or mixture intentionally used in the product
during the process of manufacturing
Generally, the new Regulation applies in 2013. Some of its provisions, however, have options
since December 1, 2010. These concern substances that are carcinogenic, mutagenic, or toxic for
reproduction (classified as CMR).
15.9.2 f ood l aBelINg
Regarding foods, the new EU Regulation 1169/2011 on the provision of food information to con-
sumers considerably changes existing legislation on food labeling including:
Nutrition information on processed foods
Origin labeling of fresh meat from pigs, sheep, goats, and poultry
Highlighting allergens, for example, peanuts or milk in the list of ingredients
Better legibility, that is, minimum size of text
Requirements on information on allergens also cover non-pre-packed foods including
those sold in restaurants and cafés
The new rules will apply beginning December 13, 2014. The obligation to provide nutrition
information will apply from December 13, 2016. The rules combine two directives into one legisla-
tion: labeling, presentation, and advertising of foodstuffs (2000/13/EC) and nutrition labeling for
foodstuffs (90/496/EEC). These directives provide for a requirement for the labeling of ingredients
in the form of nanomaterials, that is, “material plus the word 'nano' in brackets.” * Similar labeling
requirements are in place for biocides, and the said products must also have a separate evaluation of
risks from nanomaterials used.
In addition to the above, since 2006, the European Food Safety Authority (EFSA) has been fol-
lowing developments in nanotechnology within its remit—providing independent scientific advice
and technical support to risk managers, including reviewing the current state of knowledge and
latest developments in nanotechnology with regard to food and feed. In March 2009, the EFSA's
Scientific Committee, which includes the chairs of all of EFSA's Panels, published a scientific opin-
ion on nanoscience and nanotechnologies in relation to food and feed safety. A guidance document
on how to assess potential risks related to certain food-related uses of nanotechnology followed in
May 2011. It provides practical recommendations on how to assess applications from industry to use
engineered nanomaterials (ENMs) in food additives, enzymes, flavorings, food contact materials,
novel foods, food supplements, feed additives, and pesticides.
* Id.
Id.
EFSA JOURNAL. 2009. The potential risks arising from nanoscience and nanotechnologies on food and feed safety.
http://www.efsa.europa.eu/en/efsajournal/pub/958.htm.
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