HORIZON 2020 EUROPEAN UNION FUNDING FOR RESEARCH & INNOVATION

Regulating nanomaterials in the European Union Balancing risks and innovation challenges

Anthony Bochon

Table of Contents

1. Regulatory uncertainties: the EU legal framework of nanotechnologies and nanomaterials

a. 10 years of EU “nanotechnology law”: from soft law to sector-based legislation

b. The failure of the single legal definition of nanomaterials

2. The turning point: the national nanomaterials registers

a. REACH and nanomaterials

b. Comparison between the 3 national nanomaterials registers

3. Balancing risks with innovation challenges

4. Thinking “out of the box”: would a substance-based approach be better ?

5. Conclusion: is it now time for EU harmonization of nanomaterials registration requirements ?

1. Regulatory uncertainties: the EU legal framework of nanotechnologies and nanomaterials

a. 10 years of EU nanotechnology law: from soft law to sector-based legislation

FOOD SECTOR • Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16

December 2008 on food additives: the term « nanotechnologies » used in article 12 is not defined

• Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food: article 5.2 c (ii) refers to “substances deliberately engineered to particle size which exhibit functional physical and chemical properties that significantly differ from those at a larger scale”

• Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food: article 9.2 refers to “substances in the nanoform”

• Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers

• Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control

COSMETICS • Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30

November 2009 on cosmetic products CHEMICALS • Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22

May 2012 concerning the making available on the market and use of biocidal products

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1. Regulatory uncertainties: the EU legal framework of nanotechnologies and nanomaterials

b. The failure of a single legal definition of nanomaterials

• Commission Recommendation of 18 October 2011 on the definition of nanomaterial

– ‘Nanomaterial’ means a natural, incidental or manufactured material 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. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold

– By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.d between 1 and 50 %.

• Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products: article 2.1 (k)

– ‘nanomaterial’ 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

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• Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers: article 2.2 (t)

‘engineered nanomaterial’ means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.

Properties that are characteristic of the nanoscale include:

(i) those related to the large specific surface area of the materials considered; and/or

(ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material;

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• European Parliament resolution of 12 March 2014 on the Commission delegated regulation of 12 December 2013 amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers as regards the definition of ‘engineered nanomaterials’

• Novel Food draft regulation: latest amendment by the EHS committee of the EU Parliament on 24th November 2014:

– “food resulting from or affected by intentional changes in the particle size, shape or structure, or in the particle size distribution, through any technology that reduces them to nanoscale. A threshold of 10%, as recommended by EFSA, should be considered for food related applications;”

– “such substances contain or consist of any intentionally manufactured material containing particles, in an unbound state or as an aggregate or agglomerate and where, for 10% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1nm to 100nm”

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2. The turning point: the national nanomaterials registers a. REACH and nanomaterials

• Article 128 para. 1 of REACH prevents member States from taking

any measures in areas harmonized by REACH:

“Subject to paragraph 2, Member States shall not prohibit, restrict or impede the manufacturing, import, placing on the market or use of a substance, on its own, in a mixture or in an article, falling within the scope of this Regulation, which complies with this Regulation and, where appropriate, with Community acts adopted in implementation of this Regulation.”

• However, the second paragraph of article 128 of REACH allows member States to adopt or maintain measures in areas not harmonized by REACH:

“Nothing in this Regulation shall prevent Member States from maintaining or laying down national rules to protect workers, human health and the environment applying in cases where this Regulation does not harmonise the requirements on manufacture, placing on the market or use.”

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• National registers cannot apply to substances covered by REACH and whose manufacture, market placement or use are subject to harmonized requirements.

• The core question is whether the « nanos » of national registers

are substances within the meaning of article 3.1. REACH: “substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.”

• The total or partial exceptions to the scope of application of

REACH concern certain substances and use of substances, notably because these are already covered by other regulations (e.g. waste, foodstuff, cosmetics)

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• Since REACH applies to nanomaterials, the question is therefore whether REACH harmonizes the requirements on the – manufacture – placing on the market – use

of nanomaterials in order to protect – workers – human health – the environment

• Does the fact that REACH does not currently allow to distinguish nanomaterials from other substances imply that REACH does not harmonize the requirements applicable to nanomaterials ?

• There is no clear answer to this question but a NO would mean

that national nano registers are contrary to the REACH regulation.

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2. The turning point: the national nanomaterials registers b. Comparison between the 3 national nanomaterials

registers

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Comparison between the national nano registers

CRITERIA FRANCE DENMARK BELGIUM

Nature of legal basis Legislative and regulatory Legislative Regulatory

Supervising authority Ministry of Environment Ministry of Employment and Ministry

of Environment Ministry of Health

Entry into force 11st January 2013 18th June 2014 1st January 2016 & 1st January 2017

Type of control Ex-post Ex-post Ex-ante

Timeframe

Notifications must be made by 1st May

of each year for the previous calendar

year The first notifications for 2012 had to be

made by 1st July 2013

Notifications must be made by 30th

August of each year for the period

from 20th June of previous calendar

year until 20th June of the calendar

year The first notifications will be due by 30th

August 2015

Before the product is placed on the

market

Scope by product

Substance at nanoscale intentionally

produced as such, as part of a mixture

or in articles (release)

Mixtures and articles containing

nanomaterials (natural, incidental or

manufactured) intended for sale to

consumers

Manufactured nanoparticle substance

as such or as part of a mixture

Articles (not yet)

Exclusions by substance NO NO YES

Exclusions by application YES YES YES

Scope by activity

Production

Importation

Distribution to professional users

Production (marketed to consumers)

Importation (marketed to consumers)

Distribution to consumers

Production

Importation

Distribution to professional users

(only)

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Comparison between the national nano registers

CRITERIA FRANCE DENMARK BELGIUM

Activity excluded Distribution to consumers Distribution to professional users Distribution to consumers

Notification threshold 100 grams/year No threshold 100 grams/year

Simplified procedures YES

Simplified notification for R&D

YES

If some information cannot be

obtained or would be too expensive

to obtain

YES

Simplified notification for R&D

Foreign notification

Previous notification

Exemption YES

For Defence NO NO

Publicity of filing information

Annual report within 6 months of the

notification deadline

Other agencies have access to the

information for risk assessment

purposes

Annual report about notifications for

the previous period

Other agencies have access to the

information for risk assessment

purposes

Other agencies have access to the

information for risk assessment

purposes

Protection of confidential

information

Some information are deemed

confidential

Other information can be treated as

confidential upon a duly justified

request

Some information are deemed

confidential

Other information can be treated as

confidential upon a duly justified

request

Some information are deemed

confidential

Other information can be treated as

confidential upon a duly justified

request

Penalties Fine up to EUR 3.000

Daily penalty of EUR 300 Fines (undetermined)

8 days – 1 year jail

EUR 312 – EUR 720.000

Other specific requirements Information to the Health & Safety

Committee

3. Balancing risks with innovation challenges

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• The case of the national nanomaterials registers illustrates that – risks are not perceived in the same way in the EU Member States – the rules on the EU internal market are not enough taken into account – Technical and business secrets are not protected enough in the EU

• Risk of over-application of the precautionary principle when regulating nanomaterials

– The precautionary principle has no prevalence on others principles – Would an « innovation principle » be necessary ?

• All types of companies contribute to innovation in the nanotechnological sector

– Importers do not necessarily have the data to register nanomaterials – Need of costs evaluation – Risk of perception of over-regulation

• Difficulty of translating scientific uncertainties into general legal provisions

– Fast scientists vs. slow legislators ? – Role of standardization – Is the way we think the law the core issue ?

4. Thinking “out of the box”: would a substance-based approach be better ?

Pros and cons of the substance-based approach

Advantages Disadvantages

Targets only the most hazardous

substances

Discriminates companies and imposes

burdens on some while others are

exempted from legal requirements

No need to have a single definition of

the term « nanomaterial »

The multiplication of definitions could

make the legislation unreadable

Avoid regulating nanomaterials which

do not create any concern

Need to provide stronger evidence to

distinguish regulated substances from

others

Better justification in light of the EU

internal market rules

Risks of WTO disputes

Better management by the authorities Risk of discrimination by authorities

when issuing guidelines

Increase consumers confidence Create « orphan » substances

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5. Conclusion: is it now time for EU harmonization of nanomaterials registration requirements ?

• Need to clarify the competence left to the Member States when regulating chemicals

• Difficulty for companies to cope with different registration requirements (costs, language, etc …)

• No need to create a second REACH

• Avoid broad legal definitions when there are no risks related to substances caught by these definitions

• Take the consumers’ perception of registration requirements into account and its side effects

• Companies should not miss the communication challenge

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Thank you !

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Anthony Bochon Squire Patton Boggs (UK) LLP Avenue Lloyd George 7 1000 Brussels Tel: +32 2 6277628 Fax:+32 2 6271100 Email: anthony.bochon@squirepb.com