1. The Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 (CHIP3) is the GB legislation which implements several EU Directives, including the Dangerous Substances Directive (67/548/EC; DSD), Dangerous Preparations Directive (1999/45/EC; DPD) and Safety Data Sheets Directive (2001/58/EC; SDSD). There will be comparable legislation in Northern Ireland. Its purpose is to make sure that people are properly informed about the dangers of chemicals both at work and in the home. The EU Directives are updated frequently to deal with advances in knowledge about chemicals and this requires that CHIP is periodically updated to reflect these changes.
2 Under CHIP3 there is an obligation to disclose the chemical identities of hazardous chemicals on packaging labels and in safety data sheets. This is to convey important information on the ingredients that contribute to the hazard(s) of the substance or preparation. However, it has been acknowledged by the EC that such disclosure of constituents of preparations may put at risk the confidential nature of a manufacturer's intellectual property. To address this the DPD allows for confidentiality of chemical names, ie an alternative name may be used instead of the chemical name to preserve intellectual property. CHIP3 implements this provision in Great Britain.
3 HSE is the authority with responsibility for administering the applications for confidentiality in Great Britain. HSE will also deal with applications from Northern Ireland. This document gives additional information on this and also provides guidance for companies wishing to submit applications for confidentiality in the UK.
4 Provision for confidentiality of chemical names is described in Schedule 5, Part 1, paragraph 3 of CHIP3. Paragraph 3 also refers suppliers to Annex VI of the DPD. An introductory explanation is provided here.
5 Paragraph 3 Schedule 5 Part 1 (Article 15 of the DPD) defines the scope for confidentiality applications. Briefly, this only applies to chemicals that are classified as irritant (excluding chemicals that cause severe eye irritation) and/or acutely harmful. The chemical may additionally be classified for physico-chemical or environmental hazard. These classifications may be from the CHIP3 Approved Supply List if the chemical is listed, or they may be self-classifications which have taken into account all available information. The CHIP3 Approved Supply List is based on Annex 1 of the DSD. If a substance is classified for a health effect other than irritant or acutely harmful, or if it has a community occupational exposure limit, then confidentiality cannot be granted.
6 The purpose of the provision of confidentiality is to protect intellectual property. Thus, the applicant must provide justification for the application and provide reasonable evidence that disclosure of the chemical name would put the confidential nature of their intellectual property at risk.
7 HSE will process applications for confidentiality of chemical names according to the criteria detailed in CHIP3 and the DPD. The request must therefore conform with the scope defined and provide the information required in Part A of Annex VI of the DPD. The following sections are to provide additional information on how HSE has interpreted the requirements of DPD and on the preferred format of applications.
8 Confidentiality is available for preparations that are classified as dangerous (ie dangerous for health, the environment and/or with physico-chemical hazards) and those that are not classified as dangerous but require a safety data sheet in certain circumstances (a new requirement of CHIP3). HSE approval is required for classified preparations, applying the system described in this document. The person responsible for placing an unclassified preparation on the market may claim confidentiality and refer to a substance by an alternative name in the safety data sheet as long as it is done in accordance with the DPD. So, for unclassified preparations the person applies the confidentiality system themselves.
9 Applications prepared in accordance with Part A of Annex VI of the DPD may be submitted to HSE in hard-copy or electronic form by post or e-mail to the addresses listed below. Electronic documents should be in Microsoft Word, RTF or PDF format.
10 On receipt of the application HSE will confirm receipt, by e-mail (if available) or by letter, giving the name of the person responsible for processing the application and a reference number. This number should be quoted in any correspondence with HSE regarding this application.
11 We will process applications within three weeks of receipt and inform you of our decision by letter. In some cases we may request additional information if we consider it necessary in order to process the application.
12 To make the system as flexible as possible HSE envisages two types of application for confidentiality: Full Applications, which cover a single substance and a number of similar preparations containing that substance (see paragraphs 26-28), and include all the information required by the DPD Annex VI Part A. All substances for which confidentiality is claimed must have at least one full application. If a new preparation is produced that contains a substance for which confidentiality has already been granted and it is in the same group as the preparations listed in that agreement, then only a reduced application is required. This is called an Update Application.
13 The information required for Full and Update applications are different and are described below.
14 There is no formal application form. However, we would like applications to be as clear and concise as possible. The DPD Annex VI Part A provides convenient headings under which the required information can be presentedand gives a description of what is required in each of these sections.
15 We expect each application to cover a request for confidentiality for a single substance. Each substance for which confidentiality is being sought will require a Full Application of its own.
16 For successful Full Applications HSE will produce a confirmation letter to present the key details of the application, including the substance and its alternative name and a list of the preparations for which the alternative name can be used. This letter can be copied and made available to the authorities of other Member States.
17 An Update Application builds upon a previous Full Application and extends it to cover additional preparations within the same group. As such only a minimal amount of extra information is required.
18 The application should provide the HSE reference number for the previous Full Application, the name of the new preparations and a statement that the new preparations are in the same group (ie they have similar composition, the same classification and labelling and use) as those listed in the Full Application. Provided that these conditions are met then the Update Application should be successful.
19 If the application is successful, we will provide an updated acceptance letter, extending the original letter to include a full list of preparations for which the confidential name may be used.
20 No bibliography will be required when the classification of the substance has been taken from the Approved Supply List (or Annex 1 of the DPD).
21 When a substance is self-classified, a bibliography must be provided as evidence that the self-classification takes account of all existing pertinent information available on the properties of the substance. The purpose of the bibliography is to provide supporting evidence that the applicant has performed a diligent search of the scientific literature to assess the potential health hazards of the substance and to present sufficient information to allow HSE to check the classification if necessary.
22 The information presented will normally be limited to references to appropriate studies or information sources. In addition, for acute toxicity tests the LD50/LC50 values may be presented to allow a quick check that the substance is indeed harmful and in scope. Also, as the distinction between a mild and severe eye irritant (R36 and 41, respectively) is important, some indication of why the data meets the criteria for R36 could be included (for instance 'mild irritation was observed but was reversible within seven days'). It is also important to state clearly when no data for a particular end-point was found.
23 In some cases you may not have access to information on studies conducted on the substance, for instance when the supplier has conducted the testing and the study reports are confidential. In this case, you should cite any appropriate information from the supplier's SDS and state clearly that you are using the supplier's self-classification and have not actually assessed the data underlying that position.
24 In some cases there will be no data available for a particular substance, but a ‘read-across’ analysis from another similar substance is appropriate. The use of read-across is acceptable although a clear and scientifically robust argument supporting the read-across should be presented. We may accept the application based on the classification information presented but this does not represent an endorsement by HSE of this classification position.
25 Classification for physicochemical or environmental hazards does not impact directly on the application for confidentiality and so a bibliography for these hazard end-points does not need to be supplied.
26 The introductory notes of Annex VI Part A of the DPD explain that to avoid multiple requests for confidentiality relating to the same substance used in different preparations, a single request for confidentiality may suffice if the preparations have:
We will accept such grouping of preparations in the same request provided it is in accordance with the criteria described above.
27 When the preparations only contain one substance for which confidentiality is desired, the grouping is relatively easy. However, many preparations will be blends of several substances, each of which will require confidentiality. This may make appropriate grouping of preparations problematic. One possible approach is to group preparations that contain one or more of a number of substances together. By defining the concentration range of these substances as between 0 and X% the group can include preparations that contain a subset (ie one or more) of these substances, provided that the preparations all have the same classification and use.
28 Each constituent of a preparation may contribute to the overall classification of the preparation (using the conventional method defined in CHIP3). When the application covers a group of preparations that contain one or more constituents in a range of concentrations, then the applicant should take care to ensure that the classification of all the preparations in the group are the same.
29 If you are not happy with the HSE response to your application for confidentiality, you should initially contact the HSE Alternative Names team to try to resolve the issue or receive an explanation on how the decision was reached.
30 If you are still unhappy with the decision you may make a formal appeal by e-mail or in writing, to Andrew Smith, HSE, 2.3 Redgrave Court, Merton Road, Bootle L20 7HS, andrew.smith@hse.gsi.gov.uk
HSE Alternative Names Team
2.3 Redgrave Court
Merton Road,
Bootle, L20 7HS
Telephone: 0151 951 3295
Fax: 0151 951 3308
E-mail: ukconf@hse.gsi.gov.uk