Call for data on new scientific information as regards the use of hydroxyanthracene derivatives

Deadline
10 June 2017

EFSA-Q-number: EFSA-Q-2017-00265

 

Background

In the context of Article 8(2) of Regulation (EC) 1925/2006[1] on the addition of vitamins and minerals and of other substances to foods, the European Commission requested EFSA to assess the available information on the safety in use of hydroxyanthracene derivatives from all sources in foods including preparations such as food supplements and infusions. EFSA has identified rhubarb, cassia, cascara, frangula and aloe as the main botanical sources of hydroxyanthracene derivatives in foods.

In order to ensure an effective evaluation of hydroxyanthracene derivatives, it is important that EFSA retrieves from interested parties all relevant information (data, images or graphs on whatever means) for the evaluation of the selected substance. Therefore EFSA launches a public call for data in order to acquire documented information (published, unpublished or newly generated) on hydroxyanthracene derivatives.

EFSA will consider the relevance of the information provided for the risk assessment of hydroxyanthracene derivatives. The submission of the requested information is without prejudice to the final opinion of the ANS Panel.

Overall objective

The purpose of this call for data is to offer to interested parties and/or stakeholders the opportunity to submit documented information (published, unpublished or newly generated) relevant to the evaluation of hydroxyanthracene derivatives.

Deadline for submission of data and disclosure of contact details

Interested parties and stakeholders should provide by 10/06/2017 the information described below.

Within 4 weeks from the publication of this call, please communicate in writing by e-mail to: fip [at] efsa.europa.eu, your availability to submit the requested information by the timeline specified above or any proposal for a new deadline providing justified reasons.

Depending on the replies received the final deadline will be communicated to you through e-mail and by updating the current call.

In order to facilitate the collaboration of all interested parties to provide the data needed, please provide your consent to disclose your personal data (name, e-mail address and telephone number) to the other parties that has expressed an interest to provide the requested information. If you do not wish to make your contact details available, clearly indicate it in your first communication.

Information sought

EFSA kindly invites business operators and other interested parties (governments, interested organisations, universities, research institutions, companies) to submit information on hydroxyanthracene derivatives for the following specific topics:

  1. Technical data

Food supplement identification

Commercial name

 

Identity and nature of the source material

Scientific (Latin) name

full systematic species name incl. botanical family, genus, species, variety, subspecies, author’s name, and chemotype if applicable

Synonyms

botanical name(s) that may be used interchangeably with the preferred scientific name

Common names

vernacular name(s)

Part used

e.g. root, leaf, seed

Geographical origin

continent, country, region

Growth and harvesting conditions

wild or cultivated, cultivation practices, time of harvest in relation to both season and stage of the plant growth

Manufacturing process

Information on the method(s) of manufacture

e.g. the process by which the raw material is converted into a preparation, such as extraction or other procedure(s), and plant extract ratio

Information on substances entering the manufacturing process

e.g. identity of the extraction solvent, reagents, special precautions (light and temperature)

Stability in food

e.g. conditions storage, effects of storage temperature, environment and any other factor that might influence the stability

the nature and reactivity of any degradation products and nature of interaction/reaction of degradation products with food components

Standardization criteria

e.g. “see European Pharmacopoeia”

Chemical composition

Constituents to characterise the quality, chemical fingerprint, production process and/or

biological activity of the preparation (markers).

Concentrations of constituents of relevance for the safety assessment. Compounds should be classified according to their chemical structure. Levels at which the constituents are present in the respective part of the botanical or botanical preparation should be given where available

Constituents that provide reasons for concern due to their chemical, physiological or

toxicological properties

Concentrations of constituents of relevance for the safety assessment. Compounds should be classified according to their chemical structure. Levels at which the constituents are present in the respective part of the botanical or botanical preparation should be given where available.

Specifications

Should include concentrations of major groups of constituents present in the botanical preparation including for example: amino acids, lipids, polysaccharides, volatile oil, inorganic ions, polyphenols, alkaloids, terpenes, alkenylbenzenes, lignin, saponins etc. as well as the major constituents within these classes

Should also include the concentration of possible contaminants.

Proposed uses and use levels

Food supplements

Information on the recommended number of daily servings of food supplements, as suggested on the label of the product. Special attention should be given to population groups with specific uses like for example children and pregnant women. Information on the duration of the proposed uses and use levels should also be provided

Information on existing assessments

 

by international bodies

 

by national competent authorities

 

  1. Biological and toxicological data (botanical preparation and its components)

Data on absorption, distribution, metabolism and excretion

Provide references or if available, full study report.

Acute oral toxicity

Provide references or if available, full study report.

Short-term and subchronic toxicity

Provide references or if available, full study report.

Genotoxicity

Provide references or if available, full study report.

Chronic toxicity and carcinogenicity

Provide references or if available, full study report.

Reproduction and developmental studies

Provide references or if available, full study report.

Human data

e.g. data from clinical trials in humans; case reports on adverse reactions including hypersensitivity, case reports on intoxications. Provide references or if available, full study report.

Other studies

e.g. data on mode of action and any other information relevant to the safety assessment.

The requested information should follow to the extent possible, the relevant parts of the EFSA guidance on ‘Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplement’[2].

Submission of information

Interested business operators and/or interested parties should submit the information to EFSA in electronic form (e.g. CD, DVD, etc.) with a

  • cover letter that should contain:
    • Reference to the specific call and the specific EFSA question number indicated (EFSA-Q-2017-00265);
    • Reference to the substance concerned;
    • The contact detail (name of contact person, name of company/organisation, email address and telephone number) of the person responsible for the data submission and, if applicable, the list of interested business operators and/or interested parties represented and their contact details;
  • statement of the submitter that  they hold all the necessary rights to grant EFSA permission to use and, where appropriate, to disclose the submitted information, data, document, paper or study for the purposes better defined in this call. In case the submitter does not enjoy the necessary rights for these data or studies, they should share the contact details of the respective owner(s) of data and/or of the relevant intellectual property right, so that EFSA may seek their approval directly.
  • separate folders with the confidential and with the non-confidential parts.

Confidentiality

According to Article 39 of Regulation (EC) No 178/2002[3], EFSA shall not divulge to third parties confidential information received for which confidential treatment has been requested and justified, except for information which must be made public if circumstances so require, in order to protect public health. It follows that confidential treatment may be given by EFSA to information the disclosure of which might significantly harm the competitive position of business operators or other interested parties.

Therefore, the business operators and/or the interested parties who wish to benefit from confidential treatment of certain information shared with EFSA should identify which information they wish to be treated as such and provide verifiable justification supporting each request in this sense.

The provider is also requested to clearly indicate the contact details (name of contact person, name of company, email address) of the person responsible for the data submission.

Use and re-use of information

Information, data, pictures or documents shared on whatever means submitted to EFSA by the provider may be used by EFSA for the purpose clarified in the “background” and “purpose” of this call for data.

Furthermore, EFSA may use or re-use relevant information or data for purposes in the context of the discharge of its mission as set out in Article 22 of Regulation (EC) No 178/2002. This includes the possibility of re-use for the evaluation of the same or another substance under the same or a different legal or regulatory framework.

Correspondence

Please send all electronic correspondence, including enquiries to:

fip [at] efsa.europa.eu ()

Submissions should be sent to the following address:

FIP Unit, Food Additives
European Food Safety Authority
Via Carlo Magno 1/a
43126 Parma

 

[1] Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods, OJ L 404, 30.12.2006

[3] Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, OJ L 31, 01.02.2002

Published
10 April 2017