REACH Industry Update WERCS US User Group Meeting 2008 Dr. Erwin Annys Sr. Advisor Product &...

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



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.


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).


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.


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


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


REACH: The Chemical Safety Report – a state of the art




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



• 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


Use identification


Use


Environmental exposure assessment


Secondary poisoning


e-SDS


REACH: Substance Identity – the most recent information




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


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


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


Mono-constituent substances

Main Constituent % Impurity % Name

m-xylene 91 o-xylene 5 m-xylene

o-xylene 87 m-xylene 10 o-xylene

Examples


Multi-constituent substances

Main Constituents % Impurity % Name

m-xylene

o-xylene

50

45

p-xylene 5 Mixture of:

m-xylene

and

o-xylene

Example


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


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


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


Enzymes


REACH: The Authorisation Process




Authorisation

MS or Agency makes Annex XV dossier

Candidate list

Inclusion in Annex XIV

Applicat. authorisation

Authorisation granted/not

Review authorisations


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


Identification of SVHC


Prioritisation


Application for authorisation

REACH Industry Update WERCS US User Group Meeting 2008 Dr. Erwin Annys Sr. Advisor Product &...

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