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NOTOX B.V. REACH (Registration and Evaluation). SOCMA Corporate Excellence Conference 16 May 2008 Savannaha, Georgia. Core business of NOTOX B.V. Regulatory support for the notification of industrial, crop protection and biocidal products

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Notox b v

NOTOX B.V.

REACH (Registration and Evaluation)

SOCMA Corporate Excellence Conference 16 May 2008

Savannaha, Georgia


Core business of notox b v

Core business of NOTOX B.V.

  • Regulatory support for the notification of industrial, crop protection and biocidal products

  • Performance of studies for the registration of industrial and agrochemicals

  • Conduct of pre-clinical studies on APIs in support of new drug development


Track record regulatory support

Track Record Regulatory Support

Industrial and specialty chemicals:

  • HPV OECD/ICCA

    • > 50 substances

  • HPV US-EPA Test plans and gap-filling

    • > 150 substances

  • Notification dossiers EU

    • > 1,000 substances

    • consortia experience


Reach provisions

REACH Provisions

  • REACH objectives:

    • Protection of human health and environment

    • Development of hazards, use conditions and

      exposure information for existing substances

    • Compulsory sharing of information to ensure competitiveness of EU chemical industries

  • Reduce animal testing (in vitro, QSAR, read-across)

  • Responsibility for hazard information shifts from the government to the industry

  • Sustain REACH-IT portal for communication among registrants


Reach regulation

REACH Regulation

  • Evaluate existing (EINECS) substances (30,000) 2010 - 2018

  • Compile registration technical dossiers on EINECS substances – IUCLID 5

  • Reduction of testing requirements for new chemicals 1 – 10 tons

  • QSAR and alternatives for animal studies accepted, also using read-across


Reach phase in substances

REACH: phase-in substances

Tiered approach for registration

  • 2,600 substances > 1,000 MT + CMR

  • 2,900 substances 100 – 1,000 MT

  • 4,600 substances 10 – 100 MT

    20,000 substances 1 – 10 MT

    There will be one pre-registration and consortia

    building opportunity (SIEF formation) before data collection starts.


Reach exemptions

REACH: Exemptions

  • Substances under PPORD are exempted

    for 5 – 10 years

  • medicinal products including intermediates

  • waste

  • foodstuffs

  • pesticides

  • radioactive substances

  • substances in transit - customs supervision

  • cosmetics

  • Polymers are exempted (for the moment)

    .


Reach time schedule

NEW chemical guideline

(67/548/EEC) amended

REACH: Time schedule

Registration Phase

-

in substances

Phase

-

in

substances

1

10 t/y

10

100 t/y

Phase

-

in

substances

Entry into force

(EC 1907/2006)

100

1000 t/y

Phase

-

in substances

> 1000 t/y

> 100 t/y + R50/53

> 1 t/y + CMR

-

Set

up Agency

Pre

-

registration

1 June

1 June

1 Dec.

1 Dec.

1June

1June

2007

2008

2008

2010

2013

2018


Data requirements for phase in substances

Data requirements for phase-in substances

* Requires a test plan submitted to ECHA for any additional studies from Annex IX or X

CSR: Chemical Safety Report


Who is responsible

Who is responsible

  • Manufacturer of chemicals in the EU

  • Importers of chemicals, products and articles

  • Only representatives (OR) for non-EU manufacturers

    Other players:

  • Third party representatives

  • Downstream users


1 10 mt y annex vii

1- 10 MT/y (Annex VII)

  • Physico-chemical properties

  • Acute toxicity

  • Environmental toxicity and biodegradation

  • Rough costs: € 50,000 - € 65,000 or minimum $75,000


10 100 mt y annex viii

10 – 100 MT/y (Annex VIII)

  • Additional acute toxicity

  • Repeated dose toxicity

  • Reproductive toxicity

  • Additional environmental toxicity and behaviour

  • Rough costs: € 180,000 - € 220,000 or minimum $270,000


100 1 000 t y annex ix

100 – 1,000 t/y (Annex IX)

  • Additional physico-chemical

  • Further repeated dose toxicity

  • Long-term aquatic toxicity

  • Degradation and e-fate behaviour

  • Terrestrial toxicity

  • Rough costs: € 550,000 – € 1,000,000 minimum $825,000


1 000 mt y annex x

> 1,000 MT/y (Annex X)

Only after approval by authorities:

  • Additional long-term toxicity

  • Additional long-term aquatic toxicity

  • Additional terrestrial toxicity

  • Rough costs: € 1,300,000 mimimum $2,000,000


Pre registration approaches

Pre-registration Approaches

To be done between

1 June and 1 December 2008


What is needed to pre register a substance

What is needed to pre-register a substance:

  • Registration number (EINECS/CAS)

  • Chemical name (IUCLID or CAS)

  • Registrant/Contact information

  • Registration deadline and tonnage

  • Information on similar substances for QSAR and potential read-across

  • Must submit via REACH-IT portal


Prepare for sief activities

Prepare for SIEF activities

  • Determine value of data you own

  • Decide on required role in consortia (lead, active or passive member)

  • Decide on sharing company confidential information (composition data, use information)

  • Advise downstream users of REACH conformance


Test plan

Test plan:

  • Data gaps based on volume needs (Annex VII + VIII)

  • Data needs based on scientific or use considerations for Annex IX + X end-points

  • Data needs based on the outcome of the CSA/CSR

  • What can be waived using Annex XI


After pre registration

After Pre-registration

  • Companies who have pre-registered a substance will automatically become listed on the pre-SIEF page (REACH-IT) of this substance.

  • To initiate discussions after pre-registration, a pre-registrant can volunteer on the pre-SIEF page to become SIEF formation facilitator

    .

  • ECHA will publish by 1 January 2009, a list of pre-registered substances on its website. The list will comprise of all substances that have been pre-registered by 1 December 2008. For each substance the following information is displayed:

  • Substance identification: EINECS number, CAS number and names of the substance

  • Substance identification of the similar substances, if applicable

  • The first envisaged registration deadline


Registration technical dossier

Registration Technical Dossier:

  • Annex VII: ± € 3,500

  • Annex VIII: ± € 15,000

  • Annex IX: ± € 30,000

  • Annex X: ± € 39,000

    Based on setting the economic values and making robust summaries of one study per endpoint. The estimated time for a substance imported/produced in Europe above 100 MT, is a worst case estimate as only data from Annex VII and VIII are compulsory to report .


Annex xi what s in it

Annex XI: what’s in it?

  • Testing does not appear scientifically necessary

    • Use existing (non-GLP) data

    • Use historical human data

    • Weight of evidence

    • (Q)SAR possibilities

    • In vitro methods

    • Grouping and read-across

  • Testing is technically not possible

  • Substance-tailored exposure-driven testing


Reach and new chemicals non phase in substances

REACH and new chemicals(non-phase-in substances)

  • Changing of notification levels

    • < 1 ton: exempt

    • 1-10 tons: limited testing (Annex VII)

    • > 10 tons: full package (Annex VII + VIII) plus a test plan if > 100 tons

  • Introduction of in-vitro testing

  • Introduction of computer models

  • Introduction of read-across


Important websites

Important websites

http://echa.europa.eu/pre-registration

http:// echa.europa.eu/reachit

http:// echa.europa.eu/iuclid


Any questions

Thank you

Any Questions ??

Contact:

Robert B. Foster, Senior Scientific Advisor

NOTOX (USA)

Tel: 508-830-6708

E-mail: [email protected]

Website: www.notox.nl


Data packages for annex vii x

Data packages for Annex VII-X

Existing and New Substances


Test package 1 10 t a annex vii physico chemical properties

Melting point

Boiling point

Relative density

Vapour pressure

Surface tension

Water solubility

Partition coefficient

Flash point

Flammability

Explosive properties

Self-ignition temperature

Oxidising properties

Granulometry

Test Package 1 – 10 t/a (Annex VII)Physico-chemical properties


Test package 1 10 t a annex vii toxicological information

Acute oral toxicity

In vitro skin corrosion and/or in vitro skin irritation

In vitro eye irritation

Sensitisation (LLNA)

In vitro mutagenicity (Ames test)

Aquatic toxicity – Daphnia acute test

Algae growth inhibition

Biodegradation

All other available data

Test Package 1 – 10 t/a (Annex VII)Toxicological information


Test package 10 100 t a annex viii this is in addition to annex vii

Toxicity data:

In vivo skin irritation *

In vivo eye irritation *

In vitro cytogenicity in mammalian cells and/or

In vitro gene mutation in mammalian cells

* Depending on Annex VII result

Acute dermal or inhalation

28-day repeated dose

Reproductive toxicity

- Developmental screen (OECD 421 or 422)

Toxicokinetic assessment

Test Package 10 – 100 t/a (Annex VIII) This is in addition to Annex VII


Test package 10 100 t a annex viii this is in addition to annex vii1

Test Package 10 – 100 t/a (Annex VIII) This is in addition to Annex VII

Aquatic toxicology:

  • Acute toxicity with fish

  • Active sludge respiration inhibition test

  • Hydrolysis as function of pH (abiotic)

  • Adsorption/desorption screening study

  • Further degradation testing if needed


Test package 100 1000 t a annex ix this in addition to annex vii viii

Physico-chemical

properties:

Stability in organic solvents

Dissociation constant

Viscosity

Toxicological

Information:

90-day repeated dose

Teratogenicity

2-generation study

Test Package 100 – 1000 t/a (Annex IX) This in addition to Annex VII+VIII


Test package 100 1000 t a annex ix this in addition to annex vii viii1

Aquatic toxicology:

Long-term study on Daphnia

Long-term study on fish

One of the following:

-Fish ELS or

- Fish embryo and sac-fry

stages

- Fish juvenile growth

Degradation:

- further biotic studies

- Soil or sediment

simulation testing

- identification of

degradation products

E-fate/behaviour:

- fish bioconcentration

- further adsorption /

desorption studies

Test Package 100 – 1000 t/a (Annex IX) This in addition to Annex VII+VIII


Test package 100 1000 t a annex ix this in addition to annex vii viii2

Test Package 100 – 1000 t/a (Annex IX) This in addition to Annex VII+VIII

Further e-fate testing:

Effects on terrestrial organisms:

  • Acute toxicity on earthworms

  • Effects on soil micro-organisms

  • Acute toxicity to plants


Test package 1000 t a annex x this in addition to annex vii viii ix

Test Package > 1000 t/a (Annex X) This in addition to Annex VII+VIII+IX

Further toxicity testing only in agreement with authorities.

Further aquatic testing only in agreement with authorities.

Additional terrestrial studies:

  • Long-term testing on earthworms

  • Long-term testing on soil invertebrates

  • Long-term testing on plants

  • Long-term testing to sediment organisms (proposal)

  • Long-term or reproductive study on birds


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