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Changes to pre-registration after 1st December 2008

Can the bridging principle "Review of the classification where the composition of a mixture has changed" be applied where the identity of the hazardous constituents (ingredients) of a mixture change?

No, the bridging principle "Review of classification where the composition of a mixture has changed" can only be used for mixtures containing the same constituents (ingredients). It is only the concentrations of the hazardous constituents (ingredients) and not the constituents themselves that are permitted to change, within the ranges specified in Table 1.2 in Part 1 of Annex I which applies Article 15(2)(a).

If a substance did not meet the classification criteria under the Dangerous Substances Directive, is it therefore also not classified under CLP?

A substance may be classified under CLP, even though it was not under the DSD. For a range of hazards, the classification criteria have changed, e.g. for many physical hazards where the test methods which determine the classification criteria are often different from those of the DSD. For other hazards, the applicable concentration limits for taking into account the classification of its constituents, additives and impurities contained in the substance have changed, e.g. for the irritation and corrosive hazards. This means that where there is no reliable test information on the substance as a whole and the bridging principles cannot be applied, use of the calculation rules using concentration limits may lead to a classification under CLP, even though the same substance was not classified under DSD.

May a supplier use data which is available in open literature, e.g. from the internet, online databases, for the purpose of physical hazard classification under CLP?
Yes, he may, provided the data is reliable and adequate for the purpose of hazard classification. Further to this, available studies should be sufficiently documented to assess their quality and adequacy.  
The physical hazards of substances and mixtures should be determined through testing based on the methods or standards referred to in part 2 of Annex I to CLP. These methods can be found for example in the UN Manual of Tests and Criteria, which is normally used to classify substances and mixtures for transport:http://www.unece.org/trans/danger/publi/manual/manual_e.html.
However, testing is not mandatory in cases where adequate and reliable information from reference literature or databases is already available and where the substance to be classified and the substance described in the reference are comparable with regard to homogeneity, impurities, particle size etc. 
Open literature or databases often use secondary data sources. When such data is used, the original source should be cited and checked by an expert. This should involve the check that there is sufficient documentation to assess the suitability of the test used, and that the test was carried out using an acceptable level of quality assurance. Useful data compilations containing physicochemical data are listed in section R. 'Available information on physicochemical properties' of the Guidance on information requirements and chemical safety assessment on ECHA's website: http://www.echa.europa.eu/guidance-documents/guidance-on-clp
In a case where the classification for physical hazards depends on the particle size of a substance, will a supplier have to classify for all particle sizes?

No, this is not necessary. A supplier will only have to classify the substance in the form that is going to be placed on the market and in which it can reasonably be expected to be used.As the particle size may have a significant effect on the test result, it should be explicitly specified in the test report for the relevant hazard what the particle size is. This does not mean that several classifications have to be performed in order to cover different particle sizes of the same substance. It means that the classification based on the particle size that is placed on the market has to be provided. In cases where several particle sizes are placed on the market or where the particle size may be altered during transport or storage, a worst-case approach should be used. This would normally imply using the classification based on testing the smallest particle size that could occur.

If particle size is relevant for classification and safe handling and use, this should be mentioned in the Safety Data Sheet. Information on deviating classifications due to different particle sizes should be mentioned in the Safety Data Sheet as well.

In relation to the determination of the aspiration hazard of paints and varnishes: how to convert the viscosity derived from flow time measurements using a flow cup at 23°C ± 5°C according to ISO 2431 into the kinematic viscosity of the paint or varnish at 40°C?
Under CLP, the classification criteria for the aspiration hazard require the determination of the kinematic viscosity while the viscosity based on flow time is not part of the classification criteria. ISO 2431 contains correlations between flow time and kinematic viscosity. However, there is no general correlation describing the temperature dependence of the viscosity, and expert judgement is necessary.
What are the quality requirements when testing for physical hazards?

According to Article 8(5) of the CLP Regulation, where new tests for physical hazards are carried out for the purposes of this Regulation, they must be carried out, at the latest from 1 January 2014, in compliance with a relevant recognised quality system or by laboratories complying with a relevant recognised standard. The provisions of that Article are further detailed in section 2.1.5 "Quality" of the Guidance on the Application of the CLP criteria. According to the Guidance, even though the quality requirement does not become immediately effective, it is highly recommended to do so if reasonably possible. In general, the following alternative strategies can be pursued:

1. Compliance with the principles of good laboratory practice (GLP) (as formerly required by the DSD).

2. Accreditation according to EN ISO/IEC 17025 "General requirements for the competence of testing and calibration laboratories" (a relevant recognised standard).

3. Other internationally recognised standards of comparable scope.

Any testing organisation that carries out physical hazard tests for classification purposes can therefore choose how to fulfil the quality requirements of CLP.
When classifying and labelling substances that are included in Annex VI to the CLP Regulation, do I need to consider any impurities that might be relevant to classification as stipulated in Article 11(1) CLP?

Yes, you do. As stated in section of Annex VI to the CLP Regulation, impurities are not normally mentioned in Annex VI to CLP entries unless they contribute significantly to the classification of the substance. This means that the entry in Annex VI to CLP relates normally to the toxicity of the "pure" substance and impurities have not been taken into account. Therefore, if the substance placed on the market contains an impurity not specified in the corresponding entry in Annex VI to CLP, the presence of classified impurities must be taken into account for classification purposes in accordance with Article 11(1) CLP. 

As of when did the deletion of Note H in the second ATP to CLP apply to entries in Tables 3.1 and 3.2?

The Commission Regulation (EC) No 286/2011 (second ATP to CLP) entered into force on 19 April 2011. In accordance with Article 3 of this ATP, Note H is no longer applied to entries marked with the Note from 1 December 2012.

Does Article 37(6) of CLP apply to companies that possess information which obliges them to divert from the minimum classification indicated in Annex VI?
No, where a minimum classification is given in Table 3.1 of Annex VI to CLP there is no need to submit a proposal amending a harmonised classification to a Member State competent authority in accordance with Article 37(6) of the CLP Regulation in order to apply the more stringent classification.
For certain hazard classes, including acute toxicity and STOT RE, Table 3.1 of Annex VI to CLP gives a minimum classification, indicated with an asterisk. For such a minimum classification, a more severe classification shall be used when the conditions described in section 1.2.1 of Annex VI to CLP are fulfilled (Guidance on the application of CLP criteria, section 1.1.10). According to the Guidance, section, the minimum classification should only be used if no additional hazard information is available. Thus, a company must assess all information and apply a more stringent classification if appropriate and record the decision basis. A company applying a more stringent classification has therefore classified the substance in agreement with the harmonised classification in Part 3 of Annex VI to CLP.
Is it possible to ‘waive' a classification by assuming that there is no exposure based on the identified uses or uses advised against communicated in the safety data sheet under REACH?
No, this is not possible. The classification of hazards is only dependent on the intrinsic properties of a substance or mixture and exposure shall not be taken into account. 
The hazards of a substance or mixture are communicated in the supply chain via the label elements and classification/labelling in the safety data sheet. The necessary risk management measures further down the supply chain are based on that information. ‘Waiving' a classification would interrupt that flow of information down the supply chain. Therefore, it is not possible to waive the requirement for classification based on assumed lack of exposure. 
It should, however, be remembered that the form and physical state of a substance or mixture need to be considered in the framework of the hazard classification, in accordance with Articles 5 and 6 of the CLP Regulation.
Do suppliers have to comply with the harmonised classification and labelling (C&L) of a substance in Annex VI to CLP before the application date indicated in the respective adaptation to technical progress (ATP)?

A new or revised harmonised C&L of a substance set out in Annex VI to CLP must be applied from the date specified in the respective ATP, although suppliers may use this classification before that date.

In cases where a supplier decides not to apply the harmonised C&L of a substance before this date, the question arises whether they should nevertheless take into consideration the opinion adopted by the ECHA Risk Assessment Committee (RAC) on the harmonised C&L for that substance in the self-classification of a substance or mixture.

When suppliers consider the self-classification of their substance or mixture before placing them on the market (Article 4(1) of CLP), they must identify and examine all available information (Article 5 of CLP). The classification must reflect the latest scientific knowledge (Articles 5(1)(d) and 15 of CLP). During the transitional period for compliance with a new harmonised C&L for a substance, the RAC opinion for that substance should be considered as the latest reliable scientific evidence that should be reflected in the self-classification of the substance or mixture, unless the supplier has other scientific evidence that differs from the RAC opinion and leads to a different conclusion.

If the C&L of a substance is already harmonised in the same hazard class, compliance with the existing harmonised C&L is legally required until it is formally changed in an ATP to CLP. The new harmonised C&L may be voluntarily applied as soon as the respective ATP enters into force. At the date of applicability, as provided for in the respective ATP, the suppliers are obliged to comply with the new C&L.

Must you re-classify and label your biocidal product when there is a change in harmonised classification?

Yes, the classification and labelling (C&L) of biocidal products needs to be updated in line with the change in harmonised classification within the timelines specified below. If the C&L of a substance in the product is already harmonised, compliance with the existing harmonised C&L is legally required. The new harmonised C&L may be voluntarily applied as soon as the respective ATP enters into force. At the date of applicability as provided for in the respective ATP, the suppliers are obliged to comply with the new C&L.

Further to this, Article 30(3) of CLP states that the label of a biocidal product should be updated in line with the requirements of the biocidal products legislation. The Commission Implementing Regulation (EU) No 354/2013 on changes of biocidal products gives the authorisation holder 12 months after implementation of the change to notify the updated hazard and precautionary statements to all the Member States in which the product is authorised or, where relevant, ECHA (see Annex, Title 1, Section 2).

Should extreme pH be considered when classifying a mixture for skin corrosion/skin irritation or eye damage/eye irritation when it contains an Annex VI substance with a specific concentration limit (SCL) for that endpoint?

It is assumed that pH has been taken into account when setting an SCL for a substance for skin corrosion/skin irritation or eye damage/eye irritation.

When a mixture only contains one corrosive or irritant ingredient (acid or base) with an SCL, the mixture should be classified according to this SCL even if the pH of the mixture is extreme. However, the SCL reflects a situation where the mixture does not contain any other ingredient that might affect the classification for that endpoint. If other ingredients in the mixture affect the irritant/corrosive properties, this has to be taken into account.

If a mixture contains any other substances than the one with an SCL, which may affect the corrosive or irritant properties of the mixture, the SCL may not determine the classification of the mixture. Such ingredients can be surfactants, other acids or bases, which either themselves possess corrosive or irritant properties or may be expected to affect the corrosive or irritant properties of the substance with the SCL, for example, by increasing the permeability of the skin. In that case, the classification should be based on the pH value of the mixture, unless consideration of the acid/alkali reserve suggests that the mixture may not be corrosive, and data from in vitro tests confirm that classification as corrosive is not justified. Classification based on the pH value of the mixture may lead to a more severe classification than if based on the SCL. A more severe classification may also result when either the additivity rule (Tables 3.2.3 or 3.3.3 of Annex I to CLP) or non-additivity rule (Tables 3.2.4 or 3.3.4 of Annex I to CLP) applies.

How can I determine the aspiration toxicity of a mixture based on its components?

Where the aspiration toxicity of a mixture is based on its components, two conditions need to be met.

Firstly, a mixture must contain a total of 10 % or more of a substance or substances classified in Aspiration Toxicity Category 1.
Secondly, the kinematic viscosity of the mixture must be at or below 20.5 mm2/s, measured at 40°C (point of Annex I to CLP).

When these conditions are both met, the mixture must be classified in Aspiration Toxicity Category 1.

When deciding on the classification of aerosol mixtures concerning health and environmental effects, does the propellant have to be excluded?

Yes, the propellant has to be excluded, provided that it does not affect the hazardous properties of the aerosol mixture and there is scientific evidence available that shows the aerosolised form is not more hazardous than the non-aerosolised form.

The aerosol bridging principle, set out in Annex, requires the aerosol form of a mixture to be classified in the same hazard category as the non-aerosol form of a tested mixture. The bridging principle does not apply to the CMR hazard classes.

However, a similar approach should generally be used where methods, other than bridging principles, are applied for the classification of mixtures, especially for mixtures containing CMR substances. Where the calculation method includes the propellant, this results in a dilution effect of CMR substances, which is not in line with the general approach taken in CLP concerning CMR substances in mixtures. Further, this would not reflect the actual hazards of the mixture, as it is placed on the market, since the propellant normally evaporates.

It is therefore recommended to exclude the propellant for the identification of health and environmental hazards of aerosols provided that it does not affect the hazardous properties of the aerosol.

In practice, this means that, for example, when considering the classification of an aerosol, where the non-aerosolised form of a mixture contains 1.2 % of a carcinogen (Carc. cat. 2), this should be included in the classification of the aerosol regardless of the amount of propellant added. So, where a mixture consists of 33 % propellant and 67 % non-aerosolised form, which nominally would bring down the concentration of the carcinogen to 0.8 %, the mixture would still be classified.

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