The Latest Development Of EU Nano Material Regulations

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Nanomaterials

At present, EU has implemented some industrial legislation for products containing nano materials.

For example, cosmetics Ordinance No. 1223/2009 requires cosmetics manufacturers to notify relevant authorities 6 months before the launch of cosmetics containing nano materials.

In addition, the new food Ordinance requires safety assessment and authorization before new food and food ingredients containing nanomaterials are put on the market.

Furthermore, products containing nanomaterials may also be incorporated into the "substance" defined in the REACH regulations. Meanwhile, various types of obligations will be imposed on the annual imports and exports of each product produced by each manufacturer or importer in the EU.

In addition, according to the classification, labelling and packaging Ordinance (CLP Ordinance), nanomaterials that meet the classification criteria for hazardous substances must be labeled and classified and notified to the European Chemicals authority (January 3, 2011).

In addition to the current industrial EU legislation, the EU agencies have put forward a number of bills in recent months.

In July 2010, the European Parliament voted to amend the new food Ordinance to implement more stringent safety and labelling measures for foods containing nanomaterials (similar to the labeling requirements for nanomaterials in cosmetic regulations).

The bill also stipulates that any food produced by nanotechnology will not be put into the EU market unless the specific risk assessment of human health has been carried out.

The motion will stipulate an obligation that all ingredients containing nanomaterials should be listed and clearly stated "(nano)".

Interestingly, the motion's definition of nanomaterials is "one dimensional or multi-dimensional external scale or internal structure under 100 nm or below".

The amendment is currently being discussed by the European Parliament, the Council of the European Union and the European Commission, and is expected to be approved later this year.

The last EU presidency (Belgium) had proposed to create a specific registration system for nanomaterials under the EU REACH regulations.

This will require manufacturers to register products containing nano materials according to regulations.

Belgium also proposes mandatory labelling requirements for nanomaterials in consumer goods.

These proposals remain to be seen if they will be adopted this year.

In view of the concerns of nanomaterials, the most important progress at the European Union level in recent years is the draft resolution on the definition of "nanomaterials" by the European Commission in October 21, 2010.

In the draft, nanomaterials are defined as any material that satisfies at least one of the following criteria:

1. the size of 1~100 nanometer particles is composed of one dimension or multidimensional scale, and its number concentration particle size distribution (number size distribution) is greater than 1%.

2. its internal or surface structure is one-dimensional or multidimensional at 1~100 nm.

3. its surface area to volume ratio is greater than 60m? /cm? Does not include materials made up of size smaller than 1 nm.

The definition is based on the scientific opinion of the new European and New Scientific Committee on health risk.

The Committee believes that although evidence suggests that no single method can be applied to all nanomaterials, size is a key element in terms of the definition of nanomaterials.

The draft of the draft in the size of 1~100 nanometers has been criticized by stakeholders, which is considered to be limited to international standards.