Call for data on new scientific information as regards the use of monacolins (monacolin K) in red yeast rice

Deadline
3 November 2017
Document (303.94 KB)

EFSA-Q-number: EFSA-Q-2017-00681
Published: 6/10/2017
Deadline for registering interest: 3/11/2017
Deadline for submission of data: 6/12/2017

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 of monacolins in red yeast rice from all sources in foods including preparations such as food supplements.

In order to ensure an effective evaluation of monacolins in red yeast rice, it is important that EFSA retrieves from interested parties all relevant data 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 Therefore EFSA launches a public call for data in order to acquire documented information (published, unpublished or newly generated) on monacolins in red yeast rice, with specific focus on monacolin K.

EFSA will consider the relevance of the information provided for the risk assessment of monacolins in red yeast rice. 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for data is to offer to interested parties and/or stakeholders the opportunity to submit documented information (mainly unpublished or newly generated) relevant to the evaluation of monacolins in red yeast rice from all sources in foods including preparations such as food supplements.

Deadline for submission of data and disclosure of contact details

Interested parties and stakeholders should provide by 6/12/2017 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, we are seeking your consent to disclose your personal data (name, e-mail address and telephone number) to the other parties that have expressed an interest in providing 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 monacolin K 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 (e.g. flavonoids, terpenoids, alkaloids, etc.). 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 (e.g. flavonoids, terpenoids, alkaloids, etc.). 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 (and maximum limits if employed) 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.

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, including the concentration and/or the recommended daily intake of the active compounds.

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 as far as 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].

In particular, information on any potential differences (either qualitatively or quantitatively) in the biological/toxicological activity of monacolins from red yeast rice (either as a pure compound or as part of an extract) and synthetic lovastatin is strongly encouraged.

Confidentiality

According to Article 39 of Regulation (EC) No 178/2002, 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.

Submission of information

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

  • cover letter that should contain:
    • Reference to the specific call and the specific EFSA question number indicated (EFSA-Q-2017-00681);
    • Reference to the substance concerned;
    • The contact details (name of contact person, name of company/organisation, e-mail 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.

Possibility for EFSA to use the data for the safety assessment of the same or other substance under the same or other legal or regulatory frameworks.

Note that EFSA may use or re-use relevant information or data (i.e. technical, toxicological data) for the evaluation of the same or another substance under the same or a different legal or regulatory framework from the one mentioned above.

Correspondence

Please send all electronic correspondence, including enquiries to: fip [at] efsa.europa.eu

Submissions should be sent to the following address:

European Food Safety Authority
FIP Unit
Via Carlo Magno 1/a
I-43126 Parma
Italy

 


[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] The interested parties shall notify EFSA of any change in the contact details by sending an e-mail to the FIP mailbox (fip [at] efsa.europa.eu).

Published
6 October 2017