(Nanowerk Spotlight) A majority of the members of the Environmental, Public Health and Food Safety (EHS) committee of the European Parliament approved several amendments to the draft regulation on novel foods, including one imposing a moratorium on novel foods containing nanomaterials on Monday, November 24, 2014. To this day, the minutes of the committee meeting were still unavailable. However, we already know from different press releases that– The EHS committee of the European Parliament has amended the definition of the term “engineered nanomaterial” to lower the particles’ number size distribution threshold from 50% to 10%.
– The moratorium on nano-foods provides that, as long as the European Food Safety Authority (EFSA) has not approved the market placing of a novel food containing engineered nanomaterials, it cannot be placed on the market.
 
In its proposal for a regulation on novel foods, the European Commission has proposed to define the term “engineered nanomaterial” by reference to the definition given in Regulation 1169/2011 on food information to consumers.
It must be pointed out that the Commission proposed the draft regulation on novel foods on 18th December 2013, one day before it tried to amend by delegated act the definition that is still today included in Regulation 1169/2011. However, this delegated act was withdrawn by the Commission on 20th December 2013 due to intense criticism by leading members of the European Parliament.
It must therefore be understood that the Commission’s intention behind the reference to the definition provided in Regulation 1169/2011 was, in fact, to define the term “engineered nanomaterial” within the meaning of its recommendation of 18th October 2011 (pdf).
However, since the definition of Regulation 1169/2011 has not been amended yet, several members of the European Parliament have suggested that the term “engineered nanomaterial” should have its own definition in the future regulation on novel foods and not be defined by reference to another regulation.
It is interesting to note that the members of the EHS committee of the European Parliament who authored the different draft amendments to the proposal have relied on EFSA’s recommendations to justify that the number size distribution threshold should be lowered because a 10% threshold would be more relevant for food-related applications. If such definition will finally be adopted by the European Parliament and the Council of the European Union, it would mean that a single and harmonized definition of the term “engineered nanomaterial” would not be possible anymore.
It can be argued that a sector-based definition is scientifically more accurate because it can be assumed that hazards linked to the presence of manufactured nanomaterials are not the same whether the same nanomaterials are part of comestible consumer goods or not. An alternative could consist in a substance-based approach which would be a less-burdensome way to regulate the exposure of living species to potentially hazardous nanomaterials and would allow policy makers to establish priorities in terms of law enforcement and risk management.
If the “no approval-no market placing” principle will be applied to novel foods including engineered nanomaterials as defined with this 10% threshold, therefore a greater number of novel foods than foreseen by the European Commission will be subject to the authorization requirements laid down in the regulation. It is unknown whether such lower threshold would imply that more companies would have to obtain an authorization from EFSA or if the companies that would be subject to the authorization requirements with a threshold at 50% are the same as those concerned by these requirements when the threshold is at 10%. Such difference could influence the outcome of the legislative process.
Furthermore, the past experience with the Regulation 1169/2011 on Food Information to Consumers has shown that the Council of the European Union did not endorse some of the amendments brought forward by the European Parliament and that the final comprise text agreed between the Commission, the Parliament and the Council nuanced the Parliament’s amendments.
The EHS committee’s amendments to the Commission’s proposal show that the European Parliament and the European Commission clearly have two different approaches towards the regulation of nanotechnologies. Indeed, the European Parliament has adopted on 18th February 2014 a resolution condemning the Commission’s delegated regulation of 19th December 2013 that would have amended the definition of “engineered nanomaterials” in the regulation 1169/2011 on food information to consumers.
The resolution has even later been confirmed with a motion adopted on 12th March 2014 which obliged the Commission to revise its draft definition of the terms “engineered nanomaterials”. The European Parliament is perfectly aware of the challenges behind the legal definition given to nano-related substances. We cannot forget that the draft regulation on novel foods proposed by the Commission in 2008 failed by lack of consensus with the European Parliament on several issues, including those related to the inclusion of nanomaterial in novel foods. The question is now whether history will repeat again or not. 

By Anthony Bochon. Attorney at the Brussels Bar, Associate at Squire Patton Boggs (UK) LLP Brussels office, Associate lecturer at the Université libre de Bruxelles and Fellow at Stanford Law School.

Read more: European Parliament agrees on moratorium on nanofoods and on a new legal definition of engineered nanomaterials

– The EHS committee of the European Parliament has amended the definition of the term “engineered nanomaterial” to lower the particles’ number size distribution threshold from 50% to 10%.

– The moratorium on nano-foods provides that, as long as the European Food Safety Authority (EFSA) has not approved the market placing of a novel food containing engineered nanomaterials, it cannot be placed on the market.

In its proposal for a regulation on novel foods, the European Commission has proposed to define the term “engineered nanomaterial” by reference to the definition given in Regulation 1169/2011 on food information to consumers. It must be pointed out that the Commission proposed the draft regulation on novel foods on 18th December 2013, one day before it tried to amend by delegated act the definition that is still today included in Regulation 1169/2011. However, this delegated act was withdrawn by the Commission on 20th December 2013 due to intense criticism by leading members of the European Parliament. It must therefore be understood that the Commission’s intention behind the reference to the definition provided in Regulation 1169/2011 was, in fact, to define the term “engineered nanomaterial” within the meaning of its recommendation of 18th October 2011 (pdf). However, since the definition of Regulation 1169/2011 has not been amended yet, several members of the European Parliament have suggested that the term “engineered nanomaterial” should have its own definition in the future regulation on novel foods and not be defined by reference to another regulation. It is interesting to note that the members of the EHS committee of the European Parliament who authored the different draft amendments to the proposal have relied on EFSA’s recommendations to justify that the number size distribution threshold should be lowered because a 10% threshold would be more relevant for food-related applications. If such definition will finally be adopted by the European Parliament and the Council of the European Union, it would mean that a single and harmonized definition of the term “engineered nanomaterial” would not be possible anymore. It can be argued that a sector-based definition is scientifically more accurate because it can be assumed that hazards linked to the presence of manufactured nanomaterials are not the same whether the same nanomaterials are part of comestible consumer goods or not. An alternative could consist in a substance-based approach which would be a less-burdensome way to regulate the exposure of living species to potentially hazardous nanomaterials and would allow policy makers to establish priorities in terms of law enforcement and risk management. If the “no approval-no market placing” principle will be applied to novel foods including engineered nanomaterials as defined with this 10% threshold, therefore a greater number of novel foods than foreseen by the European Commission will be subject to the authorization requirements laid down in the regulation. It is unknown whether such lower threshold would imply that more companies would have to obtain an authorization from EFSA or if the companies that would be subject to the authorization requirements with a threshold at 50% are the same as those concerned by these requirements when the threshold is at 10%. Such difference could influence the outcome of the legislative process. Furthermore, the past experience with the Regulation 1169/2011 on Food Information to Consumers has shown that the Council of the European Union did not endorse some of the amendments brought forward by the European Parliament and that the final comprise text agreed between the Commission, the Parliament and the Council nuanced the Parliament’s amendments. The EHS committee’s amendments to the Commission’s proposal show that the European Parliament and the European Commission clearly have two different approaches towards the regulation of nanotechnologies. Indeed, the European Parliament has adopted on 18th February 2014 a resolution condemning the Commission’s delegated regulation of 19th December 2013 that would have amended the definition of “engineered nanomaterials” in the regulation 1169/2011 on food information to consumers. The resolution has even later been confirmed with a motion adopted on 12th March 2014 which obliged the Commission to revise its draft definition of the terms “engineered nanomaterials”. The European Parliament is perfectly aware of the challenges behind the legal definition given to nano-related substances. We cannot forget that the draft regulation on novel foods proposed by the Commission in 2008 failed by lack of consensus with the European Parliament on several issues, including those related to the inclusion of nanomaterial in novel foods. The question is now whether history will repeat again or not.  

 

By Anthony Bochon. Attorney at the Brussels Bar, Associate at Squire Patton Boggs (UK) LLP Brussels office, Associate lecturer at the Université libre de Bruxelles and Fellow at Stanford Law School.

Read more: European Parliament agrees on moratorium on nanofoods and on a new legal definition of engineered nanomaterials