EU REACH Regulation

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EU REACH Regulation

SVHC under REACH

The EU’s Black-List• The Commission established a separate procedure for chemicals

that possibly cause severe impacts on human health or the

environment

• In order to be sold in the EU or used in products sold in the EU,

these chemicals would have to obtain special Authorizationspecial Authorization.

• The EU Chemical Agency (“Agency”) would first develop a

“candidate list” of substances“candidate list” of substances to be authorised and

• prioritizeprioritize its order of authorisation basing on concerns and

consumption

SVHC – what it stands for

SVHC are:

SSubstances of VVery HHigh CConcern

require authorisation for use, special attention and reporting on:

• Manufacturing

• Storage

• Shipment

• Use

• disposal

The “CMRs”

Article 57 of 2006/121/EC (REACH

Directive):

So called CMR-SubstancesCMR-Substances

• CCarcinogenic arcinogenic and/or

• MMutagenic utagenic and/or

• Toxic to RReproductioneproduction

either category 1 or 2 according to 67/548/EC

The “PBTs”

Article 57 of 2006/121/EC (REACH

Directive):

So called PBT-SubstancesPBT-Substances

• PPersistentersistent and /or

• BBio-accumulativeio-accumulative and/or

• TToxicoxic in accordance with the criteria set out in Annex XIII of the REACH directive

This group includes the vPvB (very persistent and very bio-accumulative) Substances

SVHC – what are they?

Substances of Very High Concern are for instance:

• Polycyclic Aromatic hydrocarbons (PAHs) and aromatic

hydrocarbons found in resins, oil distillation products, tars, etc

• Azo-Dyes used for textiles, leather and food colours

• Some toxic metals such as Mercury, Lead, Chromium,

Antimony, Beryllium, Arsenic found in alloys, colours, ceramic

products, coatings, etc.

• Halons still used in coolants, refrigerators, solvents

• Halogen Carbonhydrates used in fire retardants like TBBA, other

Bromium-compounds, fluorinated compounds, etc.

• Some monomers for plastics like Vinylchloride, etc.

Where to look at (1)SVHC can be found

• Among Substances: Substances:

examples: Halons, Polycyclic Aromatic Hydrocarbons, DDT,

Azo-Compounds, Nitrosamines, Metal organic compounds,

etc…

• In Preparations: Preparations:

examples: varnishes containing halogenated solvents and

PAHs, alloys containing toxic metals like Lead, Arsenic,

Antimony, Chromium, etc; Dyes containing inorganic or organic

pigments (Cadmiumsulfide-Yellow, Azo-pigments, Chromium IV-

Green)

Note: typically any mixture that is intended to undergo a chemical

reaction (e.g. resins, epoxies, ) can potentially contain SVHCs

Where to look at (2)

But also articles articles may contain SVHCs• Coatings of products,

• Glues, resins and fillers in composites,

• Alloys in metal products,

• Fire retardants and monomers in plastic parts (e.g. TBBA as

flame retardant),

• Lubricants in mechanical parts,

Be aware and watch out for hidden SVHC’s in products

you plan to bring in.

The ThresholdNote: any content

>0,1% w/w>0,1% w/w

or

1.000kg (1mt)/a1.000kg (1mt)/a

of imported SVHC will require authorisation!

Authorisation of SVHCs

• I. “Individuals” engaged in the authorisation process Identification

• II. Duties Distribution

• III. Application for authorisation Content

I. “Individuals” in authorisation process Identification

Applicant Applicant (Manufacturer or importer) EChA EChA (as the central data host and exchange port and as part of

authorisation chain) Commission Commission (as the „decision-maker“) National Competent Authorities National Competent Authorities (as the final executive organ)

Other parties may be pulled in as the authorities feel appropriate: Consumers?Consumers? Interested Parties?Interested Parties? Other affected partiesOther affected parties

II. Duties Distribution

ApplicantApplicant: applies for an authorisation (Art. 62 I)

EChAEChA: receives application (Art. 62 I)

CommissionCommission: decision on application for authorisation (Art. 60 I)

National Competent Authorities: National Competent Authorities: enforces authorisation or prohibition of substance use

Again: Other parties may be pulled in as the authorities feel appropriate:

Consumers? Consumers?

Interested Parties?Interested Parties?

III. Application for authorisation Content

Art. 62 IV, V:Art. 62 IV, V:

identification of substance and applicant

uses of the substance for which authorisation is sought:detailed description of the use and function of the substance in that use

Chemical safety report:following the CSR from registration

Analysis of alternatives: detailed replacement asessment and results, if replacement possible: detailed substitution plan; if not: detailed reasons why

Socio-economic analysis

Additional RequirementsFor SVHC detailed information are required for entire product life span:

Exposure Scenarios and Risk Descriptions for registered/authorised uses covering the entire life span of the chemical,

Detailed description of registered/authorised uses plus warnings for unauthorised uses

Detailed description of Risk Management Measures also covering entire life span

Risk

Starting of June 2008 the ECHA works on the list of SVHC candidates

June 2009: the ECHA proposes a procedure for authorisation (Amendment XIV)

PBT and vPvBT as well as CMRs will directly become subject to authorisation

Even in case of authorisation limitations on use of SVHCs extremely likely (e.g. volumes, applications, specal safety measurements, phase out period, ...)

Target List to NGO’s?

The List of SVHCs requiring authorisation certainly will appear on the radar of groups (e.g. some NGOs) generally hostile to chemical use of Substances.

There is a real risk that these groups may influence governments to force companies not using these substances at a time where:

they have not gone through a proper risk assessment,

REACH blocks their lawful use without authorisation, and

they have not yet gone through the authorisation process.

How to get through?•Start a stringent data mining and evaluation process

•Define what is „critical“ to your business in particular (e.g. special process steps, special chemicals, sole source supply, etc)

•Establish data processing capabilities

•Create a detailed inventory of chemicals, processes and their implications

•Evaluate data to find critical issues

•Work on critical paths

See also morning session and/or later

Thank You For Your Attention

Please Feel Free To Ask Any Questions