reach: authorization procedure (rip 3.7) dr. erwin annys sr. advisor product & innovation policy...

REACH: authorization procedure (RIP 3.7)

Dr. Erwin Annys

Sr. Advisor

Product & Innovation Policy

WERCS 2007 EU User group

Napoli 31/05/07

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WERCS EU User group 2007 – Erwin Annys

Authorisation

Substances of very high concern Carcinogenic cat 1 and 2 Mutagenic cat 1 and 2 Toxic for reproduction cat 1 and 2 Persistent, bioaccumulative and toxic (PBT) Very peristent and very bioaccumulative

(vPvB) Endocrine disrupting substances, and

substances of equivalent concern not fulfilling criteria of PBT and vPvB

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AuthorisationMS or Agency

makes Annex XV dossier

Candidate list

Inclusion in Annex XIV

Application for authorisation

Authorisation granted or not

Review of authorisations

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Timing

Application date

Application

Publicationof broad info on

uses

Information on alternatives

Set deadline

up to 10 months

Cttees may jointly require info

Submission of info

RA + SEA CtteeDraft opinion

SEA Cttee may request additional info on alternatives

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Timing

Publication in OJ

Database entry

RA + SEA CtteeDraft opinion

Comments

2 months

RA + SEA Cttee Final opinion (non-confidential parts

published on website)

COMM draft decision

Decision2 months 3 months

1 month

- ApplicantKey - Interested third parties

- Agency and Committees - Commission

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Basic information that must be included in an application for an authorisation Information Guidance that is available

Identity of substance or substances covered by the application. The information given shall be based on Section 2 of Annex VI of the Regulation and shall be sufficient to enable each substance to be identified. If it is not technically possible or if it does not appear to be scientifically justified to give information on one or more of the items, the reasons shall be stated.

-Name(s) in IUPAC nomenclature or other international chemical name(s).-Other names (e.g. usual name, trade name, abbreviation).-EINECS or ELINCS number (if available and appropriate).-CAS Name and CAS number (if available).-Other identity code (if available).-Molecular and structural formula (including SMILES notation, if available).-Information on optical activity and typical ratio of (stereo) isomers (if applicable and appropriate).-Molecular weight and molecular weight range.-Degree of purity (%).-Nature of impurities, including isomers and by-products.-Percentage of (significant) main impurities.-Nature and order of magnitude (e.g. ppm, % etc.) of any additives (e.g. stabilising agents or inhibitors).

RIP 3:10: TGD for identification and naming of substances in REACH RIP 3.1: TGD on preparing a registration dossier

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Basic information that must be included in an application for an authorisation

Name and contact details of the person or person making the application.

Request for authorisation Specifying,-the use(s) for which authorisation is sought, and-covering the use(s) of the substance(s) in preparations and/or the incorporation of the substance(s) in articles, where this is relevant.

This guidance

Chemical Safety Report(s) (CSR(s))

This is only required if it has not already been submitted as part of the registration.The CSR(s) shall cover the risks to human health and/or the environment from the use(s) of the substance(s) arising from the intrinsic properties of the substance(s) specified in Annex XIV of the regulation.

RIP 3.2: Technical Guidance Document on preparing the Chemical Safety Report.RIP 3.1: TGD on preparing a registration dossier

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Basic information that must be included in an application for an authorisation

An analysis of the alternatives The analysis of alternative substances and technologies should consider,-the risks from the alternatives, -the technical and economic feasibility of substitution, and-if appropriate, information on any relevant research and development activities by the applicant.

This guidance and RIP 3.9 .

Substitution plan Where the analysis of alternatives shows that suitable alternatives are available, taking into account elements in Article 60(5), the application shall also include a substitution plan, including a timetable for proposed actions by the applicant.

This guidance.

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Other information that may be included in an application for an authorisation

Information Guidance that is available

A socio-economic analysis (SEA).

This is needed in cases where the applicant can not show adequate control of risks in accordance with section 6.4 of Annex I (taking into account article 60(3)) or the authorisation is applied for on the basis that the risk to human health or the environment from the use of the substance is outweighed by the socio-economic benefits. The SEA shall be carried out in accordance with Annex XVI of the Regulation.

RIP 3.9: Guidance on carrying out a socio-economic analysis (SEA).

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Other information that may be included in an application for an authorisation

A justification for not considering the risks to human health or environment.

This is applicable to the following situations.-Emissions of a substance from an installation for which a permit has been granted in accordance with the IPPC Directive (Council Directive 96/61/EC).-Discharges of a substance from a point source governed by the requirement for prior regulation referred to in Article 11(3)(g) of the Water Framework Directive (Directive 2000/60/EC) and legislation adopted under Article 16 of that Directive.

This guidance.

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Requirements following granting of an authorisation Requirement Organisation responsible Timeframe

Update the registration to take account of the granted authorisation {Art. 22 (2)}

Holder of authorisation Within the deadline specified in the decision

Update the Safety Data Sheet or provide downstream users with details of the authorisation {Art. 31 (9b) and Art. 32. (1b)}.

Holder of authorisation Without delay

Inclusion of authorisation number on relevant label for substance and/or preparations containing the substance {Art. 65}.

Holder of authorisation and downstream users using the substance in accordance with Art. 56 (2).

Without delay following publication of the authorisation number in the Official Journal

Notify the first supply of the substance {Art. 66 (1)}.

Downstream users using the substance in accordance with Art. 56 (2).

Within three months of first supply for the Authorised use.

Maintenance of a register of downstream users who have made a notification of supply of a substance for an Authorised use {Art. 66 (2)}.

Agency Continuous.

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Decision tree

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Alternatives

Comparative assessmentOf available substances and

techniques

Characterise end use function(s)

Consultation

Identification of possible alternatives applying technical

feasibility criteria

Potential alternative(s)

identified?yesno

Design assessment(R&D)

For novel substances and techniques

Define desired attributes (as well as technical criteria)

Environmental (e.g. P,B and T)Human health(e.g. toxicity)

Define R&D programme

Initiate R&D

Evaluate and Compare Alternatives

Environment and human health

hazards and risks

Technical performance

Economic feasibility

Suitable alternative?

Substitution plan

SEA (RIP 3.9-2)

no

yes

Technical viability / feasibility criteria

no

Manufacturer, Importer, Downstream user “Applicant”

Is the original substance a non-threshold CMR , PBT, vPvB or

equivalent properties {Article 60(3)}?

no

STOP (if alternative(s) available then application for authorisation is

unlikely to be granted)

yes

Is the original substance a non-threshold CMR , PBT, vPvB or

equivalent properties {Article 60(3)}?

yes no Submit application for authorisation

Can adequate control be demonstrated?

no yes

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Considerations on substance functionParameter Considerations for each use

Physical properties Form (e.g. particle size if applicable)

Weight

Density

Others

Chemical properties Flammability

Reactivity

Vapour pressure

pH

Others

Operational conditions Temperature

Pressure

Time restrictions from process

Time requirements of function

Scale

Process requirements

Equipment requirements

Others

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Considerations on substance functionCompatibility

Chemical compatibility

Reaction with other chemicals

Preceding or subsequent process conditions/requirements

Others

End product properties

Performance requirements, e.g. longevity, tensile or tear strength, compressibility, resistance, flame retardant

Quality of product, e.g. colour, texture

Product life, e.g. durability

Safety requirements, e.g. fire resistance

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Evaluation potential alternativesParameter Questions to be answered Alt 1 Alt 2 Alt 3

Technical feasibility / availability

Can it perform an equivalent function to the substance in question?

Will it require changes (in processes, equipment, storage facilities, training, etc.)?

Does it meet performance standards for the use

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Evaluation potential alternatives

Economic

feasibility /

availability

Availability

Is it sufficiently available to be used (e.g. sufficient volumes for a substance or units or trained personnel for a technology)

Net costs

Net compliance and other costs (taking into account both increases and decreases in costs) faced by actors in each link of the supply chain

Financial viability of the alternatives

Ability of the different actors to pass costs down the supply chain

Trade and wider economic and employment effects

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Evaluation potential alternatives

Risk assessm

ent

Human healthInformation on the hazards: properties causing the concern for the substance to be restricted / other properties

Information on risks related to properties causing the concern for the substance to be restricted / other properties. Information on other risks related to the alternatives.

Risk to the environment Information on the hazards: properties causing the concern for the

substance to be restricted / other properties

Information on risks related to properties causing the concern for the substance to be restricted / other properties. Information on other risks related to the alternatives.

Assessment of net risk Would the alternative result in a sufficient reduction in the net risk?

Are there new risks associated with the alternative?

Uncertainties. What is the level of uncertainty in the assessment of the feasibility, risks and economic feasibility of alternatives?

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Substitution plan

Element Yes

No

1.Does the substitution plan include the following basic information?

a.Name and identification number (CAS) of the chemical that is being substitutedb.Identification of alternative(s) – substances and/or technologiesc.A rationale developed to provide justification for selection of the alternative (this may be referenced out to a suitable source –e.g. analysis of alternatives or socio-economic assessment)d.A list of the barriers/obstacles/current limitations to substitutione.An action plan detailing (as a minimum) the information presented in 2. (below)f.A suitable timescale for implementation of actionsg.The method used to communicate information to stakeholders and the supply chainh.The method that will be used to report on substitution progress to the Agencyi.References to supporting information or reports (where required)

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Substitution plan2. An action plan should be developed within the

substitution plan that:a. Defines the scope and boundaries of the substitution

planb. Highlights roles and responsibilities for implementation of

the substitution planc. Identifies the actions required to implement the

substitution plan and sets realistic timescales for completion of each action (milestones) within the wider substitution plan timetable

d. Presents an understanding of the critical success factors and interdependencies

e. Highlights uncertainties in the plan and presents mitigation or justifications against these uncertainties

f. Identifies a mechanism for reviewing progress against the proposed timetable

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Substitution plan3. A substitution timetable should be presented within the

plan that:a. Contains a start-date for implementation of the

substitution planb. Contains an end-date by which substitution is anticipated

to be completec. Is realistic given the limitations identified in the

substitution pland. Contains references to suitable justifications for proposed

dates e. Highlights the milestones set within the action planf. Highlights the progress review and reporting periods

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reach: authorization procedure (rip 3.7) dr. erwin annys sr. advisor product & innovation policy...

Documents

authorisation substances

alternatives available

basic information

original substance

substance function

equivalent properties

nonthreshold cmr

criteria of pbt