Voluntary Agreement on the Approval and use of New Additives in Tobacco Products in the UK
1. Introduction
1.1 The scrutiny of additives rests with the Department of Health, acting on behalf of the UK Health Departments, taking advice from the Scientific Committee on Tobacco and Health (SCOTH) and its Technical Advisory Group (TAG) (or any successor committees) as appropriate.
1.2 The companies and the Department agree to comply with the arrangements set out in this agreement and with the procedure for obtaining approval for new additives set out in the guidelines at Appendix 1.
1.3 All information supplied to the Department will be treated in the strictest confidence.
2. Definition
2.1 An additive is any substance added by the tobacco manufacturer in the course of manufacture of a smoking product and intended to be burnt. The term "additive" relates to any substance other than water but excluding reconstituted sheet made wholly from tobacco. It includes all additives added to cigarette papers by the tobacco manufacturer, adhesives to cigarette paper and cigar seams and also includes tobacco processing agents used in the course of tobacco manufacture.
2.2 The guidelines at Appendix 1 apply to all new additives defined in Section 2.1 of this agreement. It is recognised that, in the case of new processing agents leaving no free or measurable residue and with no intentional use in the finished product, the submission may only need to demonstrate this fact.
2.3 Imprinting inks and additives to tips, filters, filter wrappers and overwrappers may continue to be used without reference to the Department.
2.4 Existing substances currently used in adhesives to cigarette paper and cigar seams, and processing agents, may continue to be used but manufacturers will supply the Department with a list of adhesives and processing agents currently in use in order that the Department may compile a historical list as for other additives.
3 . Arrangements
3.1 United Kingdom manufacturers and importers should not use non-approved additives in products marketed for sale to the public in the United Kingdom. All UK duty-free sales are excluded from the scope of this agreement.
3.2 Companies manufacturing, or importing, tobacco products marketed for consumption in the UK have the responsibility to ensure that any additive used in any of these products:
- has been approved through the Department of Health or appears in the published list of permitted additives or is authorised by another EU Member State (see Section 3.9); and
- conforms with the usage limits specified by the Department of Health and that collectively the additives are within the aggregate usage limits and are only used for the approved product style.
Companies wishing to use an additive which is authorised by another EU Member State but not previously approved through the Department of Health will notify the Department accordingly with the relevant information (see Appendix 3).
3.3 Any additives on the permitted list may be used, up to the approved level, without reference to the Department.
3.4 As a matter of routine, the Department needs UK manufacturers and importers to confirm annually that the additive usage in each tobacco product is within the individual and aggregate limits set out in the list of permitted additives or as approved by the Department. The form of this confirmation is at Appendix 2.
3.5 There may also be occasions when the Department needs information on the extent and level of use of a particular additive or combination of additives to tobacco products marketed for consumption in the UK. UK manufacturers and importers will ensure that such requests are dealt with promptly (whether they relate to new additives or additives on the permitted list). Such information will only be sought by the Department in relation to specific public health concerns and will remain strictly in confidence within the Department.
3.6 UK manufacturers and importers are not required to inform the Department of any changes in the amount of use within the agreed usage limits.
3.7 This agreement does not affect any responsibility of the UK manufacturer or importer for its products.
3.8 Companies will notify the Department when newly approved additives are included in products at the time when the products are first offered for sale to the public in the United Kingdom. Such information will remain strictly in confidence within the Department.
3.9 Those additives which are authorised by another EU Member State following assessment by a recognised scientific body, for use in the manufacture of tobacco products covered by this agreement, shall also be considered to conform with these guidelines as long as the authorisation to use the additive has been published in an official publication accessible to members of the public with an interest. The information required by the Department of Health in relation to such additives is set out in Appendix 3.
4. Publication of Information
4.1 The Department will maintain a list of approved additives with details of individual and aggregate usage limits. The list will be added to and amended in the light of submissions and notifications made by companies and other evidence available. The existence of the list will be publicised by means of a notice in the London Gazette and copies will be available from the Department. An additive will only be reported in the published list six months after it has been included in a product offered for sale in the United Kingdom unless the company has requested, in writing, that the six months' period be waived and the additive be included in the public list immediately.
Appendix 1
Guidelines for Testing and use of New Additives in Tobacco Products in the UK
Introduction
1. The following guidelines set out the arrangements for the approval of new additives to tobacco products.
2. For additives not already approved, or approved for a particular product style, or if some increase in usage limit is sought, companies will make a submission to the Department in accordance with these guidelines.
3. Individuals should not be needlessly exposed to new substances or novel uses of other substances. UK manufacturers and importers should provide the Department with sufficient information to enable it to agree inclusion and determine limits of inclusion in the finished product.
4. Submissions, and requests for information, will be based on sound toxicological information and scientifically based judgement. When the Department is not content with the scope of information provided, it will request specific additional information or clarification.
5. Following assessment, the Department may:
- give permission to use and set a usage limit. The limit will be based on toxicological evidence although it may be set lower than the highest toxicologically acceptable level. UK manufacturers and importers may not exceed this level without making a further submission. The Department may also set aggregate limits for the total level of additives in the final product;
- not give permission to use. This may be because:
- the results of toxicity testing are unsatisfactory; or
- acceptability cannot be judged on the basis of the information provided. The Department may seek additional information from the manufacturer; in that case, either a provisional recommendation will be made or the recommendation will be delayed until additional information is available.
Timing of Submissions
6. UK manufacturers and importers should not seek permission to use an additive not on the permitted list until they have a serious intention of using it in a tobacco product. Where there are no complicating factors the Department will be able to reply promptly to the submission.
7. The Department recognises that consumer acceptability tests can avoid unnecessary work in the production and consideration of full submissions on additives that are subsequently found to be unacceptable in such tests. Companies may carry out limited consumer testing, involving the provision of no more than 100 cigarettes to any individual smoker, without approaching the Department.
8. Permission for more extensive consumer testing prior to seeking formal approval for an additive will be given by the Department providing that an assessment by a suitably qualified toxicologist is supplied, indicating that there is no apparent acute hazard to those participating. Participants must be volunteers, aware that they may in the course of the test be exposed to a non-approved substance, and must be tested according to guidelines set out in the Report of the Royal College of Physicians on Research on Healthy Volunteers.1 The Department will normally reply within 30 days of the receipt of requests to carry out consumer testing. The Department may set limits on the level of individual exposure in such tests. If such limits are set, the manufacturer should not undertake any more extensive consumer testing until the Department has considered a full submission.
Form of Submission
9. The information which may be needed for the assessment and acceptance of new additives to tobacco is listed below. Some of the information requirements may not be relevant to particular substances. It will help in the consideration of submissions if companies explain why they have omitted particular information. Submissions should provide sufficient information to demonstrate to the Department's satisfaction that the additive would not increase the hazard of the product. Additives may be used for any reasonable purpose provided they are shown to be safe. The Secretariat will be happy to discuss requirements in advance of receiving a submission.
- Composition of the Additive to be Used
Examination of the structure of a substance may aid in assessing its potential toxicity. It is essential that the structure, or specification, or both, of the substance is clearly defined and is analytically and toxicologically comparable to that which will be used in the final product.
- Purpose of Using the Additive
When seeking to use an additive it is desirable that the purpose of use should be detailed.
- Status in Food, Tobacco and Drug Laws
There is a wealth of toxicological data with respect to additives used in food, drugs, cosmetics and other consumer products. However, when considering the use of such additives in tobacco products, it is necessary to demonstrate that such data is relevant to its use in material intended to be burnt and inhaled.
- The Quantity to be Used
The level of toxicity assessment is dependent on the quantity which may be received. Relevant toxicological data should be submitted which will allow the Department to set a maximum safe level of use or determine if a level requested is acceptable.
- Details of its Quantitative Transference to Smoke
Chemical analytical details will be required of the transference to smoke of the original substance.
- Destructive Distillation, Pyrolysis and Formulation of Potentially Noxious Components
It is important that as much information as is reasonable and technically possible should be given. An explanation should be provided if no data is supplied eg if the residue is too small to be measurable.
- Biological Studies
These studies would be performed after the amount to be used, its transference to smoke, and its principal metabolites are known. The Secretariat will provide advice when such studies are being planned by manufacturers and importers. However, in principle, the following would be necessary:
An Inhalational Study (Pyrolysed Tobacco Product)
Classically this should be of 90 days duration but a shorter/longer duration may be appropriate depending on the factors mentioned above.
Full details must be supplied eg:
Body Weight Data
Clinical Observations
Haematology
Clinical Chemistry
Macroscopical Data
Organ Weight Data
Histopathology of Major Organs
It is recommended that a draft protocol is submitted to the Secretariat before the work commences.
Genotoxicity
This should be carried out on:
(a) The substance itself (including, where relevant, in pyrolysed form);
(b) The condensate of a reference cigarette containing the substance
The tests required should be conducted in accordance with the Committee of Mutagenicity's Guidelines (Chapter 7).
METHODOLOGY
10. The Department will keep the guidelines under review and wherever possible, particularly in relation to paragraph 9(g), recommend methodology that obviates the need for animal testing.
Appendix 2
Certificate of Compliance
1. The Department of Health, under Section 3.4 of this Agreement, will hold a register of UK tobacco manufacturers and importers of cigarettes, cigars, hand-rolling tobacco and pipe tobaccos marketed for consumption in the UK. The UK tobacco manufacturers and importers will notify the Department of Health of the names of persons who will provide certificates of conformance for such products and will notify the Department of any subsequent changes of names of such persons.
2. Annual Certificates of Compliance (in the form atttached) will be completed by the relevant tobacco companies party to this voluntary agreement and signed by a company representative with appropriate authority.
Voluntary Agreement on Additives
Annual Certificate of Compliance for [insert name of manufacturer]
It is hereby confirmed that all tobacco products, being for these purposes any cigarettes, hand-rolling tobacco, cigars and pipe tobacco, produced by the Company ("the Company") between [date of signature] 1997 and [following year] 1998 complied with the provisions of the Voluntary Agreement on the Approval and Use of New Additives in Tobacco Products in the UK as agreed on [x 1997 - date of signature] ("the Agreement").
It is further confirmed that during the above certified period, all additives added by the Company in the course of tobacco manufacture, (as defined by Section 2.1 of the Agreement) were:-
- on the Department of Health's published permitted list or as approved by the Department;
- within the maximum usage limits as specified by the Department of Heath;
- collectively within the aggregate usage limits as specified by the Department of Health; and
- used only for the product style in respect of which they have been approved.
It is hereby confirmed that the Company will continue to abide by the provisions of the Agreement.
Position in Company:
Appendix 3
Notification of EU Authorised Additives
1. The Department of Health, as required under European Directive 83/189/EEC, and as set out in Section 3.9, will raise no objection to the use in products for consumption in the United Kingdom of an additive authorised by another EU member state. This is subject to the receipt of the following information from the manufacturer or importer who wishes to use such an additive:
- The status of the tobacco additive in the specified EU Member State's tobacco legislation, including any maximum inclusion levels.
- Any summary information concerning the current national and international status of the additives in non-tobacco consumer products.
- Details of the proposed use of the tobacco additive by product type:
- cigarette/RYO
- cigar;
- pipe tobacco.
- Details of the proposed purpose of the tobacco additive under the following headings:
- casing or flavouring ingredient;
- solvent, for the application of additive;
- tobacco sheet additive;
- cigarette paper additive;
- cigarette paper seam adhesive;
- cigar wrapper or binder seam adhesive;
- tobacco processing agent; or
- other, eg, preservative.
- Specify, if other than solvent or tobacco processing agent, whether the additive should be classified "List 1" (individually present at levels at or above 0.1%) or "List 2" (individually present at levels below 0.1%) as defined in the Department's Permitted List of Additives to Tobacco Products.
2. Where an additive has been approved for use in the UK on the basis of EU mutual recognition, this will be indicated in the Department of Health's published list of approved additives.
3. Manufacturers and importers may use extractables of tobacco, without prior approval by the Department of Health, where these have been applied to tobacco for aroma and flavour purposes and as long as the nicotine content of the finished tobacco is not measurably increased by the application of such extractables.
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