REACH Industry Update

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REACH Industry Update
WERCS US User Group Meeting 2008
Dr. Erwin Annys Sr. Advisor Product Innovation
Policy
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REACH Polymers
WERCS User Group Meeting 2008
Dr. Erwin Annys Sr. Advisor Product Innovation
Policy
3
Definition

• In accordance with REACH (Article 3(5)), a
  polymer is defined as a substance meeting the
  following criteria
• (a) Over 50 percent of the weight for that
  substance consists of polymer molecules (see
  definition below) and,
• (b) The amount of polymer molecules presenting
  the same molecular weight must be less than 50
  weight percent of the substance.

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Definition

• In the context of this definition
• A "polymer molecule" is a molecule that contains
  a sequence of at least 3 monomer units, which are
  covalently bound to at least one other monomer
  unit or other reactant.
• A "monomer unit" means the reacted form of a
  monomer substance in a polymer (for the
  identification of the monomeric unit(s) in the
  chemical structure of the polymer the mechanism
  of polymer formation may, for instance, be taken
  into consideration).

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Definition

• A "sequence" is a continuous string of monomer
  units within the molecule that are covalently
  bonded to one another and are uninterrupted by
  units other than monomer units. This continuous
  string of monomer units can possibly follow any
  network within the polymer structure.
• "Other reactant" refers to a molecule that can
  be linked to one or more sequences of monomer
  units but which cannot be regarded as a monomer
  under the relevant reaction conditions used for
  the polymer formation process.

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Additives

• A polymer, as any other substance defined in
  Article 3(1), can also contain additives
  necessary to preserve the stability of the
  polymer and impurities deriving from the
  manufacturing process. These stabilisers and
  impurities are considered to be part of the
  substance and do not have to be registered
  separately. Stabilisers include for example heat
  stabilisers, anti-oxidants (both useful during
  extrusion) and light stabilisers (e.g. for
  preservation during use). Impurities are
  unintended constituents of the polymer such as
  catalysts residues or unreacted monomers

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Polymers

• Polysaccharides, polypeptides polymers?
• Monomers?
• Polydispersity?
• Examples
• Inuline yes constituted of different monomeric
  unities (sugars) and having a polydispersity
• Enzymes no, no polydispersity
• Immunoglobulines no, no polydispersity

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REACH The Chemical Safety Report a state of
the art
WERCS User Group Meeting 2008
Dr. Erwin Annys Sr. Advisor Product Innovation
Policy
9
Chemical Safety Assesment

• A chemical safety assessment consists of
• Evaluation human health hazard
• Evaluation physicochemical hazard impact on
  human health
• Evaluation environmental hazard
• PBT and vPvB evaluation

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Chemical Safety Assesment

• If this ends up in a classification according to
  directive 67/548/EEG or 1999/45/EG or as PBT or
  vPvB
• Exposure assessment
• Risk characterisation

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Chemical Safety Assesment
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Use identification
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Use
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Environmental exposure assessment
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Environmental exposure assessment
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Secondary poisoning
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e-SDS
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e-SDS
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e-SDS
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REACH Substance Identity the most recent
information
WERCS User Group Meeting 2008
Dr. Erwin Annys Sr. Advisor Product Innovation
Policy
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Constituents

• Individual chemical species (molecules) in a
  substance are called constituents
• A substance consists of constituents
• A preparation consists of components or
  ingredients
• Constituent ? component or ingredient

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Types of substance

• Well defined substances
• Mono-constituent substances
• One main constituent 80
• Multi-constituent substances
• Two or more main constituents between 10 - 80
• In both cases ca. 100 of the composition can be
  defined

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Types of substance

• Poorly defined or variable substances
• Also known as UVCB-substances of Unknown or
  Variable composition, Complex reaction products
  or Biological materials
• Cannot be sufficiently identified by their
  composition
• Number of constituents is relatively large
• Composition largely unknown, very variable or
  poorly predictable

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Mono-constituent substances
Examples
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Multi-constituent substances
Example
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UVCB Example

• Chemical derivative of a plant extract
• Fatty acids, coco, compounds with diethanolamine
• UVCB because
• Complex mixture of amides formed from various
  fatty acids present in the coconut oil
• Ratio of fatty acids can vary in the source

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UVCB Example

• A refined product of a plant-derived substance
• Turpentine oil

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UVCB Example

• A chemical derivative of a chemical
• Reaction product of a di-carboxylic acid and
  amino-alcohol
• UVCB because
• Complicated mixture of amides and esters

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Enzymes
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REACH The Authorisation Process
WERCS User Group Meeting 2008
Dr. Erwin Annys Sr. Advisor Product Innovation
Policy
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Authorisation
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Authorisation
RIP 4.4
RIP 4.34.5
RIP 3.7
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(No Transcript)
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Identification of SVHC
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Prioritisation
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Application for authorisation
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Thanks for your attention