MANIFACTURER & IMPORTER

Transcription

1 MANIFACTURER & IMPORTER 1. Registration Dossier 2. Payment of the corresponding fee according to Title IX Substances to be registered: 1. All the substances manifacured or imported in quantities of 1 ton/year; 2. All monomers used for the production of polimer that contain a percentage of monomer > 2% and and a total quantity of 1 ton/year (both conditions verified); 3. All substances contained in articles if the total quantity is 1 ton./year and the substance is intended to be released under normal or reasonably foreseeable conditions of use.

2 Substance NOT to be registered: 1. Substances excluded from the application field of REACH Regulation (Art.2); 2. Medicines (excluded also from Evaluation and Authorization processes); 3. Substances present in food and feed, also used as food additives or flavorings (excluded also from Evaluation and Authorization processes); 4. Substances listed in Annex IV; 5. Substances listed in Annex IV; 6. Polimers (excluded also from Evaluation ). Examples of substances listed in Annex IV (Reg. 987/ th October 2008 ) Ascorbic acid glucose pure saccarose pure oleic acido CO2 Dextrin Ar N 2 Distilled water starch cellulose pulp Examples of substances listed in Annex V -Hydrates of a substance or hydrated ions, formed by association of a substance with water. -Substances which are not themselves manufactured, imported or placed on the market and which result from a chemical reaction that occurs when a substance like stabiliser, colorant, flavouring agent, plasticifer, antifoamer, dessicant ecc.. functions as intended

3 Exemption for research and development (R&D) Scientific research And Development (SR&D) Any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 tonne/year (Art. 3 (23)). NO REACH < 1 t/a Any scientific development related to product Product and Process Orientated Research and Development (PPORD) development or the further development of a substance, on its own, in mixtures or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance (Art.3 (22)).

4 Examples of PPORD activities Development and testing of a new process for the production of a substance (eg, during the rehearsal of a new catalyst) Exchange or optimization of the control parameters to improve the quality of raw materials (eg. resorting to innovative equipment, to significant changes in the mass and in the conditions of heat exchange) Testing of a new intermediate for the synthesis of a substance, (eg. for the manufacture of an active pharmaceutical ingredient (API) Development and testing of a new application (eg, the suitability for use in a new preparation)

5 PPORD e REACH to encourage innovation, substances used for products and processes oriented research and development are exempt from registration (art. 9) if not placed on the market, but made available only to a limited number of customers (specified in a list) or downstream users of which the identity is known and use them for the same research and development activity. The manufacturer or importer must demonstrate that the application of the substance requires further research before being released officially on the market.

6 Exeption for Research and Development (R&D) The obbligation to registration shall not be applied for a period of five years to a substance manufactured in the Community or imported for the purposes of product and process orientated research and development (PPORD) by a manufacturer or importer or producer of articles, by himself or in cooperation with listed customers. The manufacturer or importer or producer of articles shall NOTIFY the Agency of the following information: (a) the identity of the manufacturer or importer or producer of articles as specified in section 1 of Annex VI; (b) the identity of the substance, as specified in section 2 of Annex VI; (c) the classification of the substance as specified in section 4 of Annex VI, if any; (d) the estimated quantity as specified in section 3.1 of Annex VI; (e) the list of customers referred to in paragraph 1, including their names and addresses. The notification shall be accompanied by the fee required in accordance with Title IX.

7 The Agency may decide to extend the five-year exemption period by a further maximum of five years or, in the case of substances to be used exclusively in the development of medicinal products for human or veterinary use, or for substances that are not placed on the market, for a further maximum of ten years, upon request of manifacturer, importer or producer of article. To justify the requested extension, has to be considered The improvements and results obtained during the five years of exeption the reasons why the previous research program has not been completed within the 5 years what result it is expected to achieve during the period of extension requested. The Agency will make a decision and submit it immediately to the CA of the Member States involved to make a final decision (art. 9 (8)). The extension begins after the last day of the exemption period. There is the necessity for the notifier to anticipate the times.

8 NOTE: a substance produced / imported also for other purposes, it must be registered as any other substance and the quantity used for PPORD should not be considered in determining the amount that fall under the registration Ex. If 25 tonnes are used for PPORD, and the totally amount imported/manifactured is 74 tonnnes, the information required for the registration will be determined by the remaining 49 tonnes/year

9 Substances recicled or recovered The REACH Regulation exempts from registration substances that are registered and recovered in the Community, provided that a certain number of conditions are met. Recycling is a form of recovery and is therefore covered by this exemption. BUT SHOULD 'CLAIMS THE FOLLOWING PRINCIPLES: The recovered substance must have been registered. This means that if, for any reason, the substance has not been registered during the manufacture or import, recovered substance has to be registered following the recovery operation before being put to a new use. The substance already registered must be the same, ie have the same chemical identity and the same properties of the recovered substance.

10 Substances regarded as being REGISTERED 1. Active substances and formulation substances manufactured or imported for use exclusively in plant protection (Appendix 1 of the dir. 91/414/EEC reg.3600/92, reg. 703/2001, reg. 1490/2002, dec.2003/565 / EC); 2. Active substances manufactured or imported for use exclusively in biocidal products (Annexes I, IA, IB dir. 98/8/EC, reg. 2032/2003); 3. Substances notified under Directive 67/548/EEC: The Agency has an obligation to assign to such substances notified a registration number within 18 months of the entry into force of REACH. The notification is then rated valid only for notifier, all other parties who manufacture or import the substance must register

11 INTERMEDIATE Definition: a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance NON-ISOLATED INTERMEDIATE Outside the application field of REACH Regulation ON-SITE ISOLATED INTERMEDIATE the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities TRANSPORTED ISOLATED INTERMEDIATE isolated intermediate transported between or supplied to other sites SIMPLIFIED REGISTRATION if manifactured and used UNDER STRICTLY CONTROLLED CONDITION in that it is rigorously contained by technical means during its whole lifecycle. Control and procedural technologies shall be used to minimise emission and any resulting exposure. (Annex VI : information between 1 and 10 tonne/year)

12 Conditions for reduced set of informations Art.18(4) the substance is rigorously contained by technical means during its whole lifecycle including manufacture, purification, cleaning and maintenance of equipment, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage; procedural and control technologies shall be used that minimise emission and any resulting exposure (for example the use of physical (eg. walls) or chemical (membranes) containment barriers ). only properly trained and authorised personnel handle the substance.

13 Conditions for reduced set of informations Art.18(4) in the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered; in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures; substance-handling procedures are well documented and strictly supervised by the site operator.

14 Registration for an isolated intermediate shall include all the following information: 1) ON-SITE ISOLATED INTERMEDIATE: - the identity of the manufacturer or importer as specified in Section 1 of Annex VI; - the identity and classification of the intermediate as specified in Sections 2.1 to and Section 4 of Annex VI respectively; - any available existing information on physicochemical, human health or environmental properties of the intermediate. ; -a brief general description of the use, as specified in Section 3.5 of Annex VI - information on risk management measures applied and recommended to the user in accordance with paragraph 4 2) TRANSPORTED ISOLATED INTERMEDIATES: - The same as on-site isolated intermediates 1) - if quantities are more than tonnes per year per manufacturer or importer the registration shall include the information specified in Annex VII in addition.

15 Quantitative calculations..... in the case of other uses is the basis for the number of information Example: A factory produces/imports 2300 tonnes/year of a substance and uses1700 tonnes/year like an intermediate under stricly controlled conditions: Standard Registration only for 600 tonnes falling in the range between 100 and 1000 tonnes/ year. In the registration dossier must also communicate that produces/ imports other 1700 tonnes used as intermediate and the conditions of "strict control has to be documented The registrant has not to submit a dossier for the substance at high volume production (more than 1000 tonnes/year)

16 Substances utilized like reagents (precursors) Triphenylmethanol can be manufactured according to a Grignard reaction using magnesium, bromobenzene and benzophenone as reagents. In this example, magnesium reacts with bromobenzene. The phenylmagnesium bromide (Grignard reagent) thus formed is not isolated from the reactor, but it is further reacted in situ with benzophenone. Mg + Br MgBr Bromobenzene Phenylmagnesium bromide MgBr + O Acetophenone OH Triphenylmethanol In this specific process, both magnesium and bromobenzene are considered isolated intermediates used for the manufacture of phenylmagnesium bromide. The phenylmagnesium bromide is a non-isolated intermediate used for the manufacture of triphenylmethanol. Finally, the acetophenone is an isolated intermediate used for the manufacture of triphenylmethanol.

17 Substances utilized like reagents (precursors) The cyclopentanone can be reduced to cyclopentanol using lithium aluminum hydride (LAH) as a reducing agent. The reduction process consists in the addition of hydrogen atoms in the form of hydride present in the LAH to the carbon atom of the carbonyl function of cyclopentanone. The cyclopentanone is considered an intermediate in the manufacture of cyclopentanol because it is itself transformed into that substance. Following the same reasoning, even the LAH can be considered an intermediate because it transformed into cyclopentanol. O + H H Al - H H Li + OH A substance is not definable intermediate for its chemical nature but for the use that it gets.

18 Intermediate and articles: An intermediate is substance that is transformed into another (article 3 (15)) then it is used (article 3 par. 1 and 8) for the manufacture of a substance. An intermediate can not be used for the production of an article because it does not happen a chemical process whose main objective is to convert the intermediate into another substance. but it is just wanted to get another function This concept is further clarified through the consistent use of the words "production" and "producer" in reference to the articles and "manufacture" and "manufacturer" in relation to the substances. The same concept applies to any other industrial use of substances with the aim of providing a specific function (for example, a physical-chemical properties) through a chemical reaction reagents as coagulants / flocculants, drying reagents, ph neutralizers, etc..

19 Substance used like crosslinking agent The crosslinking agents are typically used to convert a resin into a solid mass that alone can not be further transformed, but which has been given a shape as part of a more complex product (typically an article). The substances used as crosslinkers are not intermediates under REACH, because they are not transformed into another substance but they are used to confer to a resin a specific physical property as an integrated part of a different process (eg. the production of an article). Example: the adhesive properties of epoxy-based adhesives used as an integral part in the assembly of semi-finished articles, come mainly from the in situ crosslinking of epoxy resins with a curing agent. But, the substance used as a crosslinking agent in these two-component adhesives is not an intermediate for the REACH although chemically reacts with the epoxy resin.

20 Monomer (Art.3(6)): MONOMER & POLIMER a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process. Polimer (Art. 3(5)): Substance that comprises the following: (a) a simple weight majority of molecules containing at least three monomer units (n 3) which are covalently bound to at least one other monomer unit or other reactant; (b) less than a simple weight majority of molecules of the same molecular weight (the amount of polymer molecules with the same molecular weight must be less than 50% w / w of the substance).

21 More clear with examples: A substance is composed of: 10% with n=2, 85% with n=3 5% with n=4 It 'a standard substance and not definable polymer because it has 85% w / w of the same polymer molecule with n = 3 (and therefore not less than 50%) A substance is composed of 40% w/w ( =40) of polymeric molecules (i.e. molecules with n 3): is a standard substance and can not be defined as a polymer because it doesn't meet the criterion of 50% (n 3 polymer molecules do not exceed 50%) A substance is composed of 90% w/w of polymeric molecules with n 3 ( =90): is definable polymer because none of the various components is present at a concentration greater than 50% w / w and they totally exceed 50%

22 In the polymerization process the monomer is converted into a structural unit of the polymer sequence, and this means cannot be considered monomers substances involved in catalysis, in starting or termination of the polymerization reaction. At the same time a monomer used in a chemical process is a substance intended to be used to obtain a polymer. This substance is therefore by definition an intermediate. It should be noted that according to Article 6 (2) of REACH, the reduced registration scheduled for on-site isolated intermediates and transported isolated intermediates shall not apply to monomers. This means that a full registration dossier must be transmitted even if a monomer is used as an intermediate under strictly controlled conditions. A monomer used in applications other than polymerization, it will be a normal chemical substances for REACH.

23 A monomer can find other application than take part to a polymerization processes Example: propylene can also be used for the production of propylene oxide, through a reaction of catalytic epoxidation with hydrogen peroxide. In this case the propylene can be considered like an intermediate but if it is used as a fuel gas in certain industrial processes, falls neither within the definition of intermediate or monomer and follows the general registration of a standard substance.

24 GENERAL OBLIGATION (art.6)(3)) Any manufacturer or importer of a polymer shall submit a registration to the Agency for the monomer substance(s) or any other substance(s), that have not already been registered by an actor up the supply chain, if both the following conditions are met: (a) the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s); (b) the total quantity of such monomer substance(s) or other substance(s) makes up one tonne or more per year.

25 A substance used both as a monomer and as a non-monomeric intermediate has to be registered like a "standard" substance (Art.10) unless the part of monomer used as an intermediate is handled under conditions of "strict control''. Only in this case it takes advantage of the provisions of Article 17 and 18 of REACH for the reduced data. The quantities used for the two purposes should be separated and documented Example: If you are producing 11 tonnes/year of a substance of which 2 tonnes/year are used as monomer and the remaining 9 tonnes/year as an intermediate monomeric handled under strictly controlled conditions, the information requirements for registration are based on 2 tonnes/year

26 SUBSTANCES Substances NON PHASE-IN From 1 st of June 2008 has to be applied the principle "NO DATA, NO MARKET", ie without Registration and the consent of the Agency can not produce or import the substance; Substances PHASE-IN PHASE-IN Substances under TRANSITIONAL PROVISIONS (period within which manufacturers or importers who have pre-registered will have to register the substance without interrupting their business. Such registration deadlines depend on the tonnage range of the substance) 1. Sustances placed on the market before 18 th of September 1981 and listed in EINECS 2. Manifactured in EU, but didn t placed on the market, at least once 15 years before entry into force of REACh Regulation; 3. Placed on the market in EU before entry into force of REACh and considered notified in accordance with art.8 of the Dir. 67/548 CEE.

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29 Importance of a correct identification REACH Regulation is based on substances and a correct identification is essential for: Pre - registration SIEF formation Registration and the formation of consortia Data sharing Groups of substances Classification & Labelling Comparison with other EU and national legislation International trade REACH Substance-correlate Regulation

30 Unintended constituents present in the substance. May have originated from the initial substances, or be the result of secondary or incomplete reactions during the process of production. Despite being present in the final substance have not been added intentionally. a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition Examples: preservatives (antimicrobial, anti-oxidants), thickeners, gelling agents, emulsifiers, etc... Intentionally added

31 Coming back to definition.... a chemical element and its compounds in the natural state or obtained by any manufacturing process.. Elements and pure compounds in the natural state Example: Carbon and its allotropes: graphite and diamond.. Both natural modification obtained in nature or obtained by any manufacturing process.. Example: Carbon as fullerene C60

32 . including any additive necessary to preserve its stability... namely to prevent decomposition or deterioration due to specific properties of the substance or environmental conditions, etc (ex.: catalytic decomposition due to impurities or UV radiation, oxidation, etc...)

33 . and any impurity deriving from the process used. Substances that can not be separated and that can be found in the final substance... and which may : 1. Entering the reaction through the starting material 2. Isomers not separable 3. Byproducts that are formed during the reaction but excluding any solvent which may be separated. (substance with intrinsic properties able to dissolve another substance) Note: residual of solvents non-separable are regarded as impurities.

34 without affecting the stability Ex.: It is not possible to completely separate isododecane from a solution of 18% peroxide otherwise explodes. or changing its composition

35 To be underlined. Impurities, additives and everything that is not separable can affect the classification and the behavior of the substance itself

36 Annex VI Point 2 - For each substance, the information given in this section shall be sufficient to enable each substance to be identified. If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of the items below, the reasons shall be clearly stated Name or other identifier of each substance Name(s) in the IUPAC nomenclature or other international chemical name(s) Other names (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) 2.2. Information related to molecular and structural formula of each substance 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 or molecular weight range 2.3. Composition of each substance Degree of purity ( %) Nature of impurities, including isomers and by-products Percentage of (significant) main impurities Nature and order of magnitude ( ppm, %) of any additives (e.g. stabilising agents or inhibitors) Spectral data (ultra-violet, infra-red, nuclear magnetic resonance or mass spectrum) High-pressure liquid chromatogram, gas chromatogram Description of the analytical methods or the appropriate bibliographical references for the identification of the substance and, where appropriate, for the identification of impurities and additives. This information shall be sufficient to allow the methods to be reproduced.

37 Types of sustances defined in the Guide for Identification and naming of substances under REACH and CLP : Well-defined substances: Mono-costituent substances: 1 main component 80% Multi-costituent substances more than one main constituent is present in a concentration 10% (w/w) and < 80% (w/w) In both cases 100% of composition is well-defined

38 Example : Subst. Main constituent Upper content (%) Typical content (%) Lower content (%) Impurity Upper content (%) Typical content (%) Lower content (%) Substance identity 1 o-xylene m-xylene o-xylene 2 o-xylene m-xylene p-xylene o-xylene Rule: the main constituent is always > 80%

39 Multi-costituent substances 2 or more main constituent in a range concentration between 10% and 80% A multi-constituent substance is named as a reaction mass of the main constituents of the substance. Only main constituents typically 10% contribute to the name Name defined as reaction mass of.. [main constituents] Concentration (% typical value and range) both of the main constituents (in descending order of concentration) and impurities (sum near to100%) For correct application of the 10% and 80% rule, intentionally added substances, e.g. ph-regulators or colouring agents, shall not be included in the mass balance. Note: a multi-constituent substance is not a mixture!

40 For Registration the standard approach is to register the multiconstituent substance Possibility to register the multi-constituent substance through the registration of the individual constituents In this regard, the Commission has given an interpretation of the guideline, ie

41 Commission proposal The individual constituent (A e B) can be registered and cover (A+B) registration if: There is no reduction of the necessary informations (also for the tonnage) there are sufficient data on the individual constituents to justify the approach. could prevent further testing on vertebrate animals the registration of individual constituents leads to a more efficient (eg. avoid numerous recordings of substances with the same constituent)

42 Ex. Reaction of A + B (C + D) Name = Reaction mass of C+D According to REACH: (C + D) has to be registered like they are because according to the Regulation the obbligation is to register the manifactured substances (C+D) registration is not covered by the individual registration of C and D C and D re not covered by the registration of (C+D), or (C+D+E) But.. The transition provision of phase-in substances for (C + D) is secured by EINECS numbers of the individual C and D if the hazard profile of the substances can be adequately described by the information and the available studies on the individual constituents. In conclusion, according to a more flexible approach, there is the possibility to: 1) Register (C + D) or 2) Register C and D separately and cover also the registration of (C+D)

43 Quantitative calculation A more flexible approach do not reduce the information required based on the tonnage. A multi-constituent substance (C + D) in quantity of 1200 with a composition of: 50% C (= 600 tonnes/year) 50 % D (= 600 tonnes/year) The flexible approach giving the possibility of two individual registration may led to the interpretation that information required are that for a quantity of 600 tonnes/year for each sustance (i.e. minor than 1000 tonnes/year) but. the data required for (C + D) are those listed in Annex X for substances >1000 tonnes/year

44 Example: The substance C+D+E is the product of a process inside a legal entity that manifacture also another substance: Substance1: 50% C + 25 % D + 25 % E = 1100 tpa Substance 2: 50% C + 50 % D = 500 tpa The two substances should be recorded as multi-constituenti substances. If you follow the approach of registering the individual constituents, it would be: Substance D: Tonnage: (25% of 1100) + (50% of 500) = 525 tpa C: ( 50% of % of 500) = 800 tpa E: ( 25% of 1100) = 275 tpa The number of information is based on the most severe requirement (sum of 3 substance = 1600 tpa), that however exceed 1100 tpa, which is the total quantity of multi-constituent substance "C + D + E NOTE: This example shows the information requirements and the calculation of the volumes, but does not indicate whether the approach is justifiable.

45 Example The substance G+H+I is the product of a process inside a legal entity that manifacture also another substance: : Substance 1: 65% G + 15 % H + 20 % I = 90 tpa Substance 2: 60% G + 40 % H = 90 tpa The two substances should be recorded as multi-constituenti substances. If you follow the approach of registering the individual constituents, we have: G: (65% of 90) + (60% of 90) = 112,5 tpa H: (15% of 90) + (40% of 90) = 49,5 tpa I: (20% of 90) = 18 tpa The data required are that for quantities > 100 tpa, according to the more severe requirement. NOTE: This example shows the information requirements and the calculation of the volumes, but does not indicate whether the approach is justifiable.

46 To choose the option to follow for registration should always be considered: the number of new studies involving vertebrate animals that must be performed (check if there are enough studies and whether the flexibility proposal will lead to a greater or lesser number of new tests on vertebrate animals). The choice should be on the strategy that avoids new experiments. In case of doubt, the standard route for registration should always be the registration of the substance as it is manufactured.

47 UVCB Substances Unknown or Variable composition, Complex reaction products or Biological materials Substances not uniquely specified Known with the acronym UVCBs Cannot be sufficiently identified by their chemical composition, because: The number of constituents is relatively large and/or The composition is, to a significant part, unknown and/or The variability of composition is relatively large or poorly predictable. As a consequence, UVCB require other types of information to be identified in addition to what is known about their chemical composition.

48 Generally the name of an UVCB substance is a combination of source and process: first the source and then the process. Substances originated from biological source, the identifier is the name of the specie. Substances originated from nonbiological sorce, the identifiers are the starting materials. The processes are identified by the type of chemical reaction if the synthesis of new molecules is expected, or the type of refinement (eg, extraction, fractionation, concentration...).

49 UVCB substances Complex reaction product Identification: Origin: starting materials, minerals (in generic terms e.g. phosphate ores, bauxite, china clay, mineral gas, coal, peat) Process: type of chemical reaction if synthesis of new molecules is involved; or as a type of refinement steps, e.g. extraction, fractioning, concentration; or as a residue of a refinement Additional other identifier : Generic description of chemical composition; chromatographic fingerprint or other types of fingerprint; reference material (e.g. ISO); physical-chemical parameters (e.g. boiling point); colour Index number; AISE number.

50 UVCB substances Chemicals and minerals (complex or variable composition) Reaction mixtures with poorly predictable and/or variable composition Fractions or distillates, e.g. petroleum substances, Clay (e.g. bentonite), Tars Concentrates or melts, e.g. metallic minerals, Residues of various melting or metallurgic processes, e.g. slags

51 UVCB substances Biological materials Identification: Origin: defined by the genus, species and the family e.g. Pinus cembra, Pinaceae means Pinus (genus), cembra (species), Pinaceae (family), and strain or genetic type, if relevant, part of plant/animal Process: type of chemical reaction if synthesis of new molecules is involved; or as a type of refinement steps, e.g. extraction, fractioning, concentration; or as a residue of a refinement. Other identifiers: standard enzymes index, genetic code, physical properties, function/activity, structure, amino acid sequence

52 UVCB substances Substances of biological origin Natural extracts such as fragrances, oils, natural dyes, pigments Complex macromolecules such as enzymes, proteins, DNA or RNA fragments, hormones... Fermentation products such as antibiotics, biopolymer, enzymes mixture, vinasses (products of sugar fermentation)..

53 Waste and recovered substances All forms of recovery, including mechanical processing, are considered as a manufacturing process whenever, after having undergone one or several recovery steps, they result in the generation of one or several substances as such or in a mixture or in an article that have ceased to be waste. 1 Step - Establish the IDENTITY of the substance(s) in the recovered material, including characterisation and assignment of impurities to one or more of these substances: Is the recovered substance a substance as such, or a substance in a mixture? What is the identity of the recovered substance(s)? What are typical impurities? What are typical concentrations of the impurities? To which substance(s) may these impurities be assigned?

54 Also for the recovered substances the definition of impurity depends from its pecentage : If present in quantity > 20% (w/w ): they are separate substances inside a mixture. In mechanical separation of mixed waste, it may often be impossible to derive recovered material of 100% purity (free of alien elements NOT INTENTIONAL ADDED). These alien elements are often either extraneous to the waste stream per se (for example, and depending on the waste stream, stones, plastics, pieces of rubber, sand, etc.) or extraneous to the material object of the recovery but part of the final product that became waste (for example, paints, coatings, etc.), of which the composition and total amount are difficult to determine. After appropriate sorting and separation, these fractions should be present in the recovered material only in very small quantities.

55 Even if impurities do not have to be registered separately, they need to be: IDENTIFIED and allocated to the recovered substance(s) in order to facilitate the comparison with (an)other already registered substance(s); AND EVALUATED to the extent needed for establishing the hazard profile as well as the classification and labelling of the substance as such or in a mixture in which they occur

56 In conclusion: In the context of recovered materials, it may be difficult to conclude whether a constituent of a recovered material is a substance or an impurity. in addition Recovered substances may contain impurities which may be different from those in a substance not derived from a recovery processes.