REACH Industry Update
WERCS US User Group Meeting 2008
Dr. Erwin Annys Sr. Advisor Product & Innovation Policy
2 WERCS Users group 2008Erwin Annys
REACH: Polymers
WERCS User Group Meeting 2008
Dr. Erwin Annys Sr. Advisor Product & Innovation Policy
3 WERCS Users group 2008Erwin Annys
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 WERCS Users group 2008Erwin Annys
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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REACH: Substance Identity – the most recent information
WERCS User Group Meeting 2008
Dr. Erwin Annys Sr. Advisor Product & Innovation Policy
21 WERCS Users group 2008Erwin Annys
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
Main Constituent % Impurity % Name
m-xylene 91 o-xylene 5 m-xylene
o-xylene 87 m-xylene 10 o-xylene
Examples
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Multi-constituent substances
Main Constituents % Impurity % Name
m-xylene
o-xylene
50
45
p-xylene 5 Mixture of:
m-xylene
and
o-xylene
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
EC 263-153-4 CAS 61790-63-4 Condensation products of coco fatty acids and diethanolamine
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UVCB Example
• A refined product of a plant-derived substance:• Turpentine oil
EC: 232-350-7 CAS: 8006-64-2 Any of the volatile predominately terpenic fractions or distillates resulting from the solvent extraction of; gum collection from, or pulping of softwoods. Composed primarily of the C10H16 terpene hydrocarbons: alpha-pinene, beta-pinene, limonene, 3-carene, camphene. May contain other acyclic, monocyclic or bicyclic terpenenes, oxygenated terpenes and anethole. Exact composition varies with refining methods and the age, location and species of the softwood source
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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
EC 294-006-2 CAS: 91672-02-5 Reaction products of nonanedioicacid and 2-amino-2-methyl-1-propanol
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REACH: The Authorisation Process
WERCS User Group Meeting 2008
Dr. Erwin Annys Sr. Advisor Product & Innovation Policy
31 WERCS Users group 2008Erwin Annys
Authorisation
MS or Agency makes Annex XV dossier
Candidate list
Inclusion in Annex XIV
Applicat. authorisation
Authorisation granted/not
Review authorisations
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Authorisation
MS or Agency makes Annex XV dossier
Candidate list
Inclusion in Annex XIV
Applicat. authorisation
Authorisation granted/not
Review authorisations
RIP 4.4
RIP 4.3&4.5
RIP 3.7