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The French Nano Decree: A model for Europe?

Jean-Philippe Montfort

Partner, Mayer Brown International LLP

NIA Symposium, 19 December 2012

The Context: Nanomaterials (NMs) under REACH

• REACH covers NMs but no specific provision causes concerns (e.g. 1 ton threshold, substance sameness, risk assessment)

• Commission’s recommended definition

• Legislative developments in e.g. cosmetic, food contact, biocides, medical devices

• Guidance revisited through RIP-oNs

• NGO’s proposal for a « nanopatch »

• Request for action from 10 Member States

• ECHA stepping up activities on NMs through Dossier Evaluation and Article 36 requests

• Commission 2nd regulatory review: Case by case approach to assessment of NMs under REACH … no legislative proposals

Various Initiatives on the Reporting on NMs

• UK (2006): Voluntary reporting scheme

• France (2009-2010): First legislation calling for mandatory reporting

• Other initiatives (2008-2010) in AU, GE, SW, BE, NL

• Sept 2010: Belgian Presidency proposal for EU mandatory reporting

• July 2012: 10 Member States (AT, BE, CZ, DK, FR, IT, LU, NL, ES, SE) request Com to adopt e.g. legislation on registration of NMs or products containing NMs (or other market surveillance mechanisms)

• Aug 2012: France adopts final decree on NMs mandatory reporting

• Oct 2012: Com Communication: “Current knowledge about NMs does not suggest risks which would require information about all products in which NMs are used”. Com proposes a “web platform” to include registries on a national or sector level, where they exist

• Dec 2012: 10 Member States contest the Commission’s view

• Dec 2012: DK EPA: Mandatory reporting would hamper innovation

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France: Grenelle de l’Environnement

• 2007: Country wide consultation on sustainable development (« Le Grenellle de l’environnement »)

• Commitment No 157: Anticipate the risks linked to the production and use of manufactured NMs

• Grenelle Law No 1 (2009-967): Art 41 calls for:

– A mandatory reporting scheme of the quantities and uses of manufactured NMs

– Supply of information to the public and consumers

– Increased information on risks of NMs and protection measures to employees

• National public debate also required traceability and better risk assessment

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France: Current Legal Situation • Legal framework is now complete:

– Article 185 of the Law no 2010-788 of 12 July 2010. Creates a new

chapter in the French Environment Code (on the prevention of the

risks due to the exposure to subtances at the nanoscale) and

provides the principle of a mandatory reporting scheme

– Decree on the annual declaration of substances at the nanoscale

of 17 Feb 2012 (Décrêt n° 2012-232)

– Ministerial Order (Arrêté) relating to the content and submission

conditions of annual declarations of 6 Aug 2012

– Decree No 2012-233 establishing right of access of other agencies

• Mandatory reporting scheme enters into force on 1 January

2013

Decree 2012-232 on Annual Declaration • Enters into force on 1 January 2013

• Broad Scope: Applies to:

– any manufacturer, importer or distributor

– of a "substance at the nanoscale”

– as a whole or as part of a mixture without being bound, or in articles intended to release such substances under normal or reasonably foreseeable conditions of use,

– who produces, imports or distributes (to professionnals)

– at least 100 grams per year of this substance.

• Declaration is to be sent to Ministry of Environment yearly before 1 May of each year, relating to the previous calendar year.

• First declaration required before 1 May 2013 for 2012!

Decree 2012-232 on Annual Declaration (2) • Electronic submission, IUCLID-based (links with REACH)

• Protection of confidential information (because some information is considered a priori confidential; other can be claimed and justified as confidential)

• Reduced declaration for R&D (also automatically granted confidential treatment)

• Non-confidential information will be made publicly available within 6 months of declaration deadline (by 1 November every year)

• Other Agencies have a right of access to the declared information for risk assessment purposes

• Fine for non-compliance of up to € 3000 and a daily penalty of € 300 from the time of the decision until the time the obligations are satisfied

Definition of Substance at the Nanoscale

EU Recommendation French Decree

‘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 between 1 and 50 %.

Substance at the nanoscale means a substance as defined in Article 3 of REACH, intentionally manufactured at the nano scale, containing particles, in an unbound state or as an aggregate or as an agglomerate, and where for a minimal proportion of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm.

Number size distribution threshold set at 50% under Order of 6 August 2012, can be lowered “where warranted by concerns for the environment, health, safety or competitiveness”.

Declaration form: Order of 6 August 2012

• Entry into force 1 January 2013 • Declaration content (part is considered automatically confidential):

I. ldentity of the declarer

II. ldentity of the substance (All confidential except chemical name)

III. Quantity of the nanoparticle substance produced, distributed or imported over the past year in kg (confidential)

IV. Uses of the nanoparticle substance (Commercial name is confidential)

V. ldentity of professional users to whom the declarer has transferred ownership of the substance (confidential)

• (Other information to be claimed and justified as confidential) • Number is assigned to all declarations • That number must be provided with all transfers of ownership to

professional users and distributors so that they can make their declaration with reference to suppliers declaration (instead of fill in part II above)

• Non-EU producers can appoint EU representative to make declaration and relieve EU importers, in which case the importer can refer to the supplier declaration number provided to him

Declaration: Information on Substance Identity

Mandatory Optional

Chemical identification of the substance (chemical name, formula, CAS/EC no, commercial name)

REACH registration no (digits identifying declaring entity can be omitted)

Particle size: average particle diameter, standard deviation, determination method used

lmpurities: nature and quantity of impurities present above 0.1% mass concentration if mandatory under other laws

Particle size distribution by number: distribution curve of sizes by number, determination method used

Crystalline state: nature of crystallographic phases and, in the case of a mixture of phases, proportion of each of the phases

State of aggregation and agglomeration: average size of aggregates and agglomerates, standard deviation if available, determination method used

Specific surface: average specific surface, standard deviation, method used

Form: qualitative description, determination method used

Surface charge: zeta potential, if available, specifying medium and pH conditions

Surface coating: qualitative description, if applicable

State: substance as such, contained in mixture (solid/liquid/gas/powder), or released from article

Expected Difficulties of Application

• Scope:

– Broad definition of a « substance at the nanoscale »

– Unclear definition of a « subtance at the nanoscale in a mixture without being bound »: intentionally added and susceptible of being extracted or liberated under normal or reasonably previsible conditions of use

• Entry into force:

– Not sure it is known to all players

– Will 2012 data be traceable?

• Supply chain issues:

– Upstream communications needed. With what success?

• Enforcement difficulties

Legality of the French Nano Decree under REACH

• REACH (and the CLP) fully harmonizes the conditions for the manufacture, placing on the market and use of nanomaterials, including:

– The legal basis for the adoption of REACH (Article 95)

– The objectives of REACH (Article 1.2)

– The REACH legislative history (White Paper, free movement clause, EP ENVI amendment on nanomaterials rejected)

• Possible application of Articles 128.2 of REACH? – Article 128.1: 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 preparation 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.

– Article 128.2: 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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Legality of the French Nano Decree (2)

• If full harmonization, then there is no scope for additional Member States measures, except in the framework of REACH:

– Prepare an Annex XV dossier to subject a substance at the nanoscale to the REACH Authorisation or Restriction process

– Take a « provisional measure » on the basis of:

• Article 129 of REACH allows MS to take appropriate provisional measures where it has “justifiable grounds for believing that urgent action is essential to protect human health or the environment in respect of a substance (...)” even if the substance satisfies the requirements of the REACH Regulation.

• The MS must immediately inform the Commission/ECHA /other MS. It is then for the Commission to review the MS measure and either authorise or require the MS to reject it, or instigate the restriction procedure under REACH

• Article 114(5) TFEU allows MS to introduce national provisions but only based on:

– “new scientific evidence” relating to the protection of the environment or the working environment

– on the grounds of a problem “specific to that MS” arising after the adoption of the harmonised measure.

– Difficulty: Any such action is to be justified for a specific substance

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Notification under Directive 98/34/EC

• If one considers that Article 128.2 allows MS to take a national measure on nanomaterials, there is still scope for the Commission to oppose the measure

• Directive 98/34/EC requires MS to immediately communicate to the Commission any «draft technical regulation» with a statement of the grounds for taking that measure

• Question as to whether a «reporting system» is a «technical regulation» that requires reporting, but France did notify its Decree and Arrêté

• Upon notification, MS must postpone adoption of the measure for 3 months… then a further

– 6 months if it received a reasoned opinion from the Commission or another MS that the measure creates obstacles to trade

– 12 months if the Commission respond that the measure concerns a matter for which it has the intention to propose EU legislation

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Where are we today? What will happen next?

• Lack of complaint from Industry on the illegality of the French reporting scheme

• Lack of action by the Commission against the French Reporting scheme

– Opens the door to other challenges to the Single market (e.g. notification system for chemicals manufactured or marketed below 1 ton per year)

– Opens the door to 26 other, possibly different, national reporting schemes

• Difficult for the Commission to object other national schemes if it allowed the adoption of the French Decree

• But the Commission can still oppose further schemes if it creates a reporting scheme at the EU level

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Thank you for your attention!

Mayer Brown Strong Roots, Global Reach

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