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European Parliament
| Report Title: |
Position (EU) No 6/2010 of the Council at First Reading With a View to the Adoption of a Regulation of the European Parliament and of the Council on Novel Foods, Amending Regulation (ec) No 1331/2008 and Repealing Regulation (ec) No 258/97 and Commission Regulation (ec) No 1852/2001 |
| Report ID: |
515 |
| Date: |
5/11/2010 |
| Report Type: |
Legislation |
| URL: |
[LexUriServ.do] |
| Country: |
European Union |
| Organization: |
European Parliament |
| Summary: |
After the European Parliament previously (see report ID 138) suggested revising the European novel food laws, the European Parliament has adopted its first-reading position on draft regulation concerning novel foods. This legislation intends to stimulate the development of innovative foods while ensuring a high level of food safety and consumer protection. Notably, the approval process for novel foods is now streamlined, with all applications submitted to the European Commission for a risk assessment by the European Food Safety Authority (EFSA). The Commission can now approve new novel foods by a committee procedure. Previously, food applications had to be sent to all member states and the Commission for safety assessment and commenting, with any member state able to raise objections. This legislation also clarifies the definition of novel food to include food produced from cloned animals and to include any food containing or consisting of engineered nanomaterials. |
| Archived Copy: |
5976144_060410_515_5198.pdf |
 |
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| Report Title: |
Regulation (EC) No 1907/2006 of the European Parliament and of the Council |
| Report ID: |
502 |
| Date: |
12/18/2006 |
| Author: |
European Parliament and European Council |
| Report Type: |
Legislation |
| URL: |
[LexUriServ.do] |
| Country: |
European Union |
| Organization: |
European Parliament |
| Summary: |
In 2006, the European Parliament and European Council enacted REACH. REACH (Registration, Evaluation, Authorization, and restriction of Chemical Substances) requires all manufacturers or importers of chemical substances to register the substances with the European Chemicals Agency (ECHA) if the quantity is greater than one tonne per year. The nature of nanomaterials means that many nanomaterials which would otherwise be subject to regulation are not covered under REACH because they do not reach the one tonne threshold. REACH was subsequently modified in 2008 (see report ID 99) to add additional chemicals. |
| Archived Copy: |
REACH_502_6277.pdf |
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|
| Report Title: |
Meps Back Tougher Rules for Nanotechnology |
| Report ID: |
481 |
| Date: |
4/28/2009 |
| Author: |
EurActiv |
| Report Type: |
News Article |
| Publication: |
EurActiv.com |
| URL: |
[article-181695] |
| Country: |
European Union |
| Organization: |
European Parliament |
| Summary: |
On April 24, 2009, the European Parliament adopted the Schlyter Draft Report on regulatory aspects of nanomaterials (see report ID 74 and amendments in ID 192). The report calls for all nanomaterials to be considered as new substances, and was approved by a vote of 391-3. The European Environmental Bureau (EEB) and consumer group BEUC welcomed the adoption of the report, believing it will create a safe legislative framework for regulating nanotechnology. REACHforLIFE and an executive director at chemical industry body CEFIC were opposed to the report, claiming it could create "confusion and information overkill." |
| Archived Copy: |
MEPs back tougher rules_481_9977.pdf |
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| Report Title: |
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products |
| Report ID: |
455 |
| Date: |
11/30/2009 |
| Author: |
European Parliament and the Council of the European Union |
| Report Type: |
Legislation |
| URL: |
[LexUriServ.do] |
| Country: |
European Union |
| Organization: |
European Parliament |
| Summary: |
Regulation (EC) No. 1223/2009 is the first EU regulation to include a dedicated provision expressly designed to review the safety of nanomaterials. This new regulation repeals the former cosmetics regulation (Council Directive 76/768/EEC) and the existing national laws on cosmetic products. The regulation takes effect on July 11, 2013, with products containing carcinogenic, mutagenic, or toxic to reproduction substances being regulated as of December 1, 2010. All cosmetic products will be subject to a safety assessment and to a premarket notification and approval procedure. Every product is required to name a "responsible person" who is responsible for ensuring compliance with the regulation and for informing authorities if the product poses a risk to human health. Distributors of cosmetic products are also held responsible for ensuring that the products they distribute are in compliance with labeling requirements for nanomaterial-containing substances. Both the responsible person and the distributor are required to inform the authorities of any serious biological effects from the product they have placed on the market. Additionally, products must be traceable both from the responsible person to all distributors and vice versa. The responsible person also must keep product information on file for ten years from the last batch of a product is placed on the market. The required safety assessment includes a product safety report with data requirements (listed in Annex I). The safety report must provide quantitative and qualitative composition, physical/chemical characteristics, toxicological profile, etc. It must be updated if new information is available after the product is placed on the market. The regulation also creates a centralized electronic notification procedure for new cosmetic products, provides a definition of nanomaterials, and establishes specific safety and labeling requirements for nanomaterial-containing cosmetic products. |
| Archived Copy: |
LexUriServ_455_4507.pdf |
|
|
| Report Title: |
Texts Adopted: European Parliament Legislative Resolution of 25 March 2009 on the Proposal for a Regulation of the European Parliament and of the Council on Novel Foods and Amending Regulation (ec) No Xxx/xxxx |
| Report ID: |
141 |
| Date: |
3/25/2009 |
| Author: |
European Union |
| Report Type: |
Survey |
| URL: |
[getDoc.do] |
| Country: |
European Union |
| Organization: |
European Parliament |
| Summary: |
On March 25, 2009, the European Parliament approved a legislative resolution calling for regulation on novel foods within the EU. This resolution, developed after the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Internal Market and Consumer Protection and the Committee on Agriculture and Rural Development, explicitly expresses a clear priority for a high level of human health protection even if this impairs the functioning of the EUs internal market. Novel foods must be subjected to rigorous scientific examination before they can be approved for consumption. Furthermore, such regulation must apply to all foods on the EU market, including foods imported from third countries. Cloned foods or foods derived from cloned animals or components thereof are also prohibited. Nanomaterials present in food packaging must be on an approved list and the rate of migration into the contained food products must be known and limited. The declarations of this resolution are either already incorporated or are intended to be incorporated into future EU legislation regarding novel foods. |
| Archived Copy: |
Michael Vincent European Parliament (2009) Texts adopted - Tuesday 24 March 2009 - Cosmetic products (r _141_7390.pdf |
|
|
| Report Title: |
European Parliament Legislative Resolution of 24 March 2009 on the Proposal for a Regulation of the European Parliament and of the Council on Cosmetic Products (recast) (com(2008)0049 C6-0053/2008 2008/0035(cod)) |
| Report ID: |
140 |
| Date: |
3/24/2009 |
| Author: |
European Union |
| Report Type: |
Legislation |
| URL: |
[getDoc.do] |
| Country: |
European Union |
| Organization: |
European Parliament |
| Summary: |
The EUs Council Directive 76/768/EEC, which regulates cosmetic products, has been amended 55 times since its creation in 1976. Developments in nanotechnology necessitate changes to the Directive as well. In order to simplify the European regulatory environment, the entire Directive has been rewritten, streamlined, and purged of legal uncertainties. This document contains the full text of the new legislation, now in the form of a regulation rather than a directive. This regulation requires manufacturers of cosmetic products containing nanomaterials to notify the European Commission six months in advance of commercial availability. Such notification must include the type and quantity of nanomaterials, toxicological profiles, safety data, and predicted exposure conditions. A new labeling requirement mandates that any nanomaterial ingredients be included in the products ingredient list followed by the word nano enclosed in brackets. |
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