FoodChain ID Service Proposal

This Service Proposal (“Proposal”) is between the FoodChain ID Group, Inc., located at 504 North 4th Street, Fairfield, Iowa 52556 USA (“FoodChain ID”) and Client, located at the address listed on the Proposal. FoodChain ID and Client are collectively the “Parties.” The Proposal identifies the Parties’ rights, obligations, and understanding regarding the Service as identified in the attached Proposal.

Confidentiality. During the Proposal period, Client and FoodChain ID may obtain the other’s proprietary and confidential information. Each party agrees to protect the other’s confidential information with the same degree of care that it gives to its own confidential information but with not less than reasonable care.

(a) The Client’s Confidential Information: FoodChain ID may acquire or develop confidential information relating to the Client, including the status of Client products, practices within its facilities, information disclosed by Client, and other technical and business information about it or its vendors.

(b) FoodChain ID owes the Client a duty to hold all such confidential or proprietary information in the strictest confidence and not to disclose it to any person, firm or corporation or to use it except as necessary in carrying out the services for the Client consistent with FoodChain ID’s Proposal with the Client. The Client agrees and consents in writing to the release of any such confidential or proprietary information related to the formulas or the audit results to FoodChain ID, as may be necessary for FoodChain ID to complete its Proposal service. FoodChain ID agrees to protect such proprietary information of the Client with the same degree of care that it gives to its own confidential information but not less than reasonable care. FoodChain ID also agrees not to release confidential information to any party without the express written consent of the Client which may be the legal or rightful owner of such proprietary or confidential information. FoodChain ID shall notify Client immediately upon discovery of, or suspicion of, (i) any unauthorized use or disclosure of Confidential Information by FoodChain ID or its representatives; or (ii) any actions by FoodChain ID or its representative inconsistent with its obligations under this Proposal , FoodChain ID shall cooperate (means took reasonable steps to assist the Client to rectify the error) with any effort of the Client to help the Client regain possession of Confidential Information and prevent its further unauthorized use.

(c) FoodChain ID’s Confidential Information: The Client may obtain proprietary and confidential information from FoodChain ID, which includes FoodChain ID’s forms and documents, questionnaires, written and oral advice, methods of verification and other aspects concerning the Proposal service, and constitutes the intellectual property of FoodChain ID. The Client may disclose all FoodChain ID information to persons who are under a duty of confidentiality at least as stringent as the Client’s hereunder, and who have a need to know such information in connection with the Client’s business purposes, provided that such disclosures by the Client of FoodChain ID’s proprietary and confidential information (including forms, documents and questionnaires) shall not be made to other administrators of any program similar to or competitive with FoodChain ID by allowing such administrators to use the Client’s passwords to access its data online or otherwise.

FoodChain ID’s services, including FoodChain ID processes and its online data acquisition and management system (including the specific fields and definitions in the questionnaire and the reporting formats used) are based on information and standards owned by FoodChain ID and shall remain the property of FoodChain ID or, as applicable, and the Client shall have no rights therein.

(d) Confidential information of a party does not include information that a party can establish by written records is (i) in the public domain through no fault of receiving party, (ii) known to the receiving party prior to disclosure by the disclosing party, (iii) transferred or disclosed to the receiving party by a third party without violation of the disclosing party’s rights, and (iv) developed by a party without reliance on the disclosing party’s confidential information.

(e) Permitted Disclosures: Notwithstanding the foregoing, the following permitted disclosures are agreed upon:
i. The information received from the Client, and FoodChain ID’s advice or information provided to the Client, may be aggregated with other information in the FoodChain ID database and used by FoodChain ID and/or on a purely no-name basis where the Client’s or any particular product’s identity is not disclosed or identifiable by those familiar with the industry in any such summary or aggregation report during the term of this Proposal and thereafter without regard to termination of this Proposal agreement.

ii. Once the Client’s service is completed by FoodChain ID as in compliance with the Proposal, the Client’s brand and trade names, marks, and Client-supplied logos may be disclosed to the public by FoodChain ID . Client would receive advance notice prior to use. (Applicable only to consumer facing Verification and/or Certification programs).

(f) In the event that any party receives a request to disclose all or any part of the confidential information of the other under the terms of a valid and effective subpoena or order issued by a court of competent jurisdiction or by a governmental or banking regulatory body, unless unlawful to do so, the receiving party shall promptly notify the disclosing party so it may seek a protective order and, at no out-of-expense to the receiving party, cooperate with the disclosing party in obtaining the protective order, and only release pursuant to the subpoena or order so much of the confidential information as is necessary to comply with the subpoena or order.

(g) In the event of any breach or threatened breach of the confidentiality provisions above, the non-breaching party shall be entitled to a temporary or permanent injunction, without the necessity of posting any bond or other security, in addition to any monetary damages that may be awarded.

(h) Each party shall be responsible for any breach of confidentiality by any person that received a party’s confidential information from the other party (“Representatives”), which includes Representatives who subsequent to obtaining the confidential information become former Representatives of the other party. Each party shall take, at its sole cost and expense, all reasonable measures, including but not limited to court proceedings, to restrain its Representatives from unauthorized disclosure or use of the confidential information. Except for disclosure to its Representatives under the conditions noted above or as otherwise permitted under this Proposal, each party shall retain the other party’s confidential information in secret, shall not utilize the confidential information for the benefit of the receiving party or any third party, and shall not divulge, furnish, or make accessible the confidential information to any third party.

(i) Each party’s obligations respecting the confidential information disclosed by the other party shall remain in effect (i) with respect to a trade secret (which, for the avoidance of doubt, includes without limitation Client formula, ingredient sourcing and product processing information), for so long as such information remains a trade secret under applicable law and (b) for all other confidential information, for a period of ten (10) years from the date of disclosure of said confidential information.

Payment Terms. In the event that credit has been granted by FoodChain ID, Customer will pay all invoiced amounts within the stated term (Net 30 payment terms for all services) of the invoice date as indicated on the invoice. Customer agrees to pay all collection costs, including reasonable attorney’s fees and court costs incurred by FoodChain ID Testing in collecting such past due amounts. FoodChain ID, in addition to any other remedies available, may suspend all further services for Customer until all past due amounts, late payment charges, and collection costs are paid.
Limitation of Liability/Indemnification. The Client understands any certificate issued by FoodChain ID hereunder is based on FoodChain ID’s determination that, to the best of FoodChain ID’s knowledge, the Client is operating in compliance with the applicable program. The Client further understands that, among other things, testing product samples is not a guarantee that all product(s) will conform to the analysis results of levels of the samples that are tested, and product may otherwise fail to satisfy applicable requirements of laws or contracts.
THE MAXIMUM LIABILITY OF FOODCHAIN ID TESTING AND ANY OF ITS EMPLOYEES, DIRECTORS, CONTRACTORS, OR OTHER REPRESENTATIVES FOR ACTS OR OMISSIONS IN CONNECTION WITH ANY ANALYSIS, TESTING, OR OTHER SERVICES FOR CUSTOMER SHALL BE THE AMOUNT PAID BY CUSTOMER (OR ITS AFFILIATE OR SUBSIDIARY) FOR THE ANALYSIS, TESTING OR OTHER SERVICES THAT RESULTS IN CUSTOMER’S LOSS. THIS LIMITATION SHALL NOT APPLY TO: 1) GROSS NEGLIGENCE OR MORE CULPABLE ACTS OR OMISSION (INCLUDING RECKLESSNESS OR WILLFUL MISCONDUCT); 2) BAD FAITH FAILURE TO MATERIALLY COMPLY WITH ANY OF THE MATERIAL OBLIGATIONS SET FORTH IN THIS AGREEMENT; OR 3) FRAUD. THE FOREGOING WARRANTY AND AGREEMENT IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED, AND FOODCHAIN ID TESTING SHALL NOT, UNDER ANY CIRCUMSTANCES, BE LIABLE FOR INDIRECT, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR ANY DAMAGES IN THE NATURE OF LOST PROFITS, OR FOR INJURY OR HARM TO ANY PERSON.
Indemnification. The Parties hereby agree to defend, indemnify and hold the other party, its affiliates, licensors, contractors, and service providers, and its and their respective officers, directors, employees, contractors, agents, licensors, suppliers, successors, and assigns harmless from any third party claims, liabilities, damages, demands, judgments, awards, losses, costs, expenses, or fees, including reasonable attorneys’ fees, arising out of or relating to a party’s violation of this Proposal, gross negligence, or willful misconduct, and/or the party’s violation of any law or the rights of any third party.
Subcontracting. FoodChain ID may subcontract all or any portion of its services to one or more third parties, and may assign this Agreement to any related party or purchaser of all or substantially all of FoodChain ID’s business or assets. Otherwise, neither party may assign or transfer any right or obligation under this Agreement without the prior written consent of the other party.
Force Majeure. Neither party is responsible for delay or failure to perform resulting from acts beyond such party’s reasonable control (“Force Majeure”) and the party’s obligations that cannot be reasonably performed shall be suspended for the Force Majeure period. Force Majeure includes but is not limited to acts of God, government acts or omissions, war, riots or strikes, epidemics, fires, floods, or other disasters.
Third-Party Representation. If either party uses a third-party (for example, but not limited to, an independent contractor, broker, or other non-employee representative and/or agent) representative and/or agent to act on its behalf under this Proposal and in its interactions with the other party, then the parties agree (1) the party will disclose the identity of this third-party to the other party; (2) the party understands this is an ongoing obligation and if they create or terminate a third-party representative relationship throughout the term of this Proposal that the party will disclose these changes to the other party.
Disputes/Governing Law. Any dispute(s) arising out of or relating to this Agreement shall be governed by the laws of the State of Delaware. Either party may seek recourse to the state or federal courts situated in Delaware to enforce the confidentiality provisions of this Agreement. In the event of any dispute, the prevailing party shall be entitled to all costs of resolving the dispute, including reasonable attorney’s fees. In the event FoodChain ID incurs any expenses, including reasonable attorney fees, resulting from collecting past due invoices, such expenses, costs and fees shall be borne by the Company.
General. If any provision of this Proposal is determined to be void or overbroad, such provision shall be automatically reduced in scope to the maximum legal protection that could be obtained by Client to protect its Confidential Information and the remainder of the Proposal shall remain in full force and effect.
Counterparts. This Proposal may be executed in two or more counterparts, each of which will be considered an original, but all of which together will constitute one and the same instrument. A PDF or any other type of copy of an executed version of this Proposal signed by a party is binding upon the signing party to the same extent as the original of the signed agreement.
Titles. The titles used in this Proposal are used for convenience only and are not to be considered in construing or interpreting this Proposal.
Entire Proposal. This Proposal shall constitute the entire understanding of the parties with respect to the Confidential information and supersedes any prior agreements, understandings regarding the subject matter hereof. No modification, amendment, or waiver may be accomplished to the terms of this Proposal without the prior written consent of both parties. No failure or delay by a party in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any single or partial exercise thereof preclude any other further exercise or the exercise of any other right, power or privilege hereunder. This Proposal may be executed and delivered in counterparts and via facsimile or other electronic transmission, each of which shall be deemed an original and all of which, taken together, shall constitute one and the same document.

On November 17, 2022, the U.S. Food and Drug Administration (FDA) sent warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent cardiovascular disease (or related conditions, such as atherosclerosis, stroke, or heart failure).

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), products intended to diagnose, cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements.

Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to these warning letters are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns. Thus, the products cited in these letters are unapproved new drugs.

The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law.

Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

On November 21, 2022, the U.S. Food and Drug Administration (FDA) sent warning letters to five companies for illegally selling products containing cannabidiol (CBD).

According to the FDA, these companies are selling CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD. CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning according to the FDA.

These warning letters also outlined additional violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including that several of the companies are illegally selling unapproved CBD products that claim to cure, mitigate, treat or prevent various diseases, and adding CBD to animal foods, such as pet treats.

Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

Recently, the U.S. Food and Drug Administration (FDA) concluded that beta-nicotinamide mononucleotide (NMN) is excluded from the definition of a dietary supplement and may not be marketed as or in a dietary supplement because NMN is “an article authorized for investigation as a new drug by the FDA”.

The FDA decision is based on a provision in the Federal Food, Drug, and Cosmetic Act (FD&C Act), known as the “drug preclusion” provision, stating that if an article, in this case NMN, has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, the article may not be marketed as or in a dietary supplement unless the article was marketed as a dietary supplement or as a food before being authorized for investigation as a new drug (21 U.S.C. § 321(ff)).

The FDA made this determination in a response to a New Dietary Ingredient Notification (NDI 1259) from Inner Mongolia Kingdomway Pharmaceutical Ltd (Kingdomway). Prior to releasing this response letter, the agency did not conclude that NMN was excluded from the definition of a dietary supplement due to being investigated as a drug in response letters to five New Dietary Ingredient Notifications (NDINs) filed with FDA between 2020 and 2022. Moreover, the FDA had acknowledged without objection a New Dietary Ingredient Notification for β-NMN from SyncoZymes (Shanghai) Co. Ltd on May 16, 2022 (NDI 1247).

As a result, in November the FDA sent letters communicating this new conclusion simultaneously to all firms that have submitted an NDI notification for NMN.

Commission Delegated Regulation (EU) 2022/2182 of 30 August 2022 amending Delegated Regulation (EU) 2017/1798 as regards the lipid and magnesium requirements for total diet replacement for weight control was published in the Official Journal of the European Union on 9 November 2022 and is entered into force on 29 November 2022 (without transition period).

This regulation amends Annex I of the delegated regulation (EU) 2017/1798:

Deletion of the minimum linoleic acid content
Reduction of the minimum alpha-linolenic acid content “The alpha-linolenic acid contained in total diet replacement for weight control products shall not be less than 0,8 g for the total daily ration” (instead of 1.4g previously)
Increase of the maximum magnesium content (≤ 350mg instead of 250mg previously)

Reminder: the Delegated Regulation (EU) 2017/1798 supplementing Regulation (EU) No 609/2013 as regards the specific compositional and information requirements for total diet replacement for weight control is applicable instead of Directive 96/8/EC since 27 October 2022.

In July 2022, the European Commission sent requests to EFSA to provide scientific opinions on the safety of three substances according to article 8 of Regulation (EC) 1925/2006:

Berberine (and plant preparations containing it), following a request by the French authorities
Hydroxycitric Acid (and plant preparations containing it, particularly Garcinia gummi-gutta), following a request by the Spanish authorities
Bitter and sweet fennel (presence of estragole), following a request by the German authorities.

EFSA has accepted these three requests in November and should provide those scientific opinions in May 2025 at the latest.

Regulation (EU) 2022/2340 of 30 November 2022 amending Regulation 1925/2006 as regards green tea extracts containing EGCG was published on 1rst December in the Official Journal of the European Union and will apply from 22 December 2022. Foodstuffs containing green tea extracts containing (-)- epigallocatechin-3-gallate, which do not comply with the requirements of this Regulation and were lawfully placed on the market before 21 December 2022 may remain on the market until 21 June 2023.

This regulation adds green tea extracts containing (-)- epigallocatechin-3-gallate (excluding aqueous green tea extracts containing (-)- epigallocatechin-3-gallate which after reconstitution in beverages have a composition comparable to traditional green tea infusions) :

– in Part B of Annex III to Regulation (EC) 1925/2006 (under restrictions):

Dose of EGCG < 800 mg / day (to be indicated on the label: content of (-)- epigallocatechin-3-gallate per portion of the food and maximum number of portions of the food for daily consumption). Mandatory warnings: warning not to consume a daily amount of 800 mg of (-)-epigallocatechin-3-gallate or more. “Should not be consumed if you are consuming other products containing green tea on the same day”. “Should not be consumed by pregnant or lactating women and children below 18 years old”. “Should not be consumed on an empty stomach”.

– and in Part C of Annex III to Regulation (EC) 1925/2006, i.e. under Union scrutiny (under scrutiny because of scientific uncertainty: the industry will have to submit additional scientific data demonstrating the safety of the substances for a possible new assessment by EFSA; and the Commission should take a decision within four years).

Concretely, it corresponds to:

– a ban of green tea extracts containing a daily dose of EGCG greater than or equal to 800 mg/day

– and for lower doses: placing under restrictions (mandatory warnings) and under Union scrutiny.

Regulation (EU) 2022/1922 of 10 October 2022 amending the Annex to Regulation (EU) No 231/2012 laying down specifications for food additives has updated the specifications of the currently authorised food additive ‘Enzymatically produced steviol glycosides’ (E 960c):

– update of the specifications for E 960c(i) Rebaudioside M produced via enzyme modification of steviol glycosides from Stevia

– addition of specifications for rebaudiosides M, D and AM produced via enzymatic conversion of puriﬁed stevia leaf extracts:

E 960c(ii) Rebaudioside M produced via enzymatic conversion of highly purified rebaudioside A Stevia leaf extracts
E 960c(iii) Rebaudioside D produced via enzymatic conversion of highly purified rebaudioside A Stevia leaf extracts
E 960c(iv) Rebaudioside AM produced via enzymatic conversion of highly purified stevioside Stevia leaf extracts.

As a reminder, on 29 July 2022, the Belgian Authorities notified the European Commission of a draft text amending the annex to the Royal Decree of 31 August 2021 on the manufacture of and trade in foodstuffs consisting of or containing plants or plant preparations.

The modifications are linked to some recommendations of the Advisory Commission for Plant Preparations (example: Tinospora cordifolia) as well as the reassessment of the novel food status of around forty plants present in list 3 (positive list of plants for food supplements) (example: Pelargonium sidoides considered as novel food).

The consultation period for the draft text at European level has been postponed from 31 October 2022 to 30 January 2023, in particular because of a detailed opinion from the French authorities.

The European associations Food supplements Europe and EHPM also submitted contributions concerning this draft text, indicating that questioning the non-novel food status of plants on a positive list for many years would undermine legal certainty.

In October 2021, the French Authorities notified the European Commission of a draft text classifying the main form of vitamin D (cholecalciferol) as having endocrine disrupting properties, adding an obligation to inform the consumer on this subject (article 13 of the AGEC law, supplemented by decree 2021-1110, providing the provision of information to consumers allowing the identification of endocrine disruptors in a product).

As the European Commission, several Member States and many associations issued comments to the French authorities in the context of this notification, in particular concerning vitamin D used as a nutrient, the French authorities have requested an opinion on this subject from ANSES.

On 26 October 2022, ANSES published a detailed note and a communication indicating that it advises against including vitamin D3 in the list of substances to be mentioned as endocrine disruptors on food products, as part of implementation of the French AGEC Act.

Cholecalciferol was identified as an endocrine disruptor (ED) during its assessment by the European Chemicals Agency under the Biocides Regulation (EU) No 528/2012.

However, ANSES stresses that the doses of cholecalciferol used in biocidal products to eradicate rodents are far higher than the doses of vitamin D provided by a normal diet, including foods fortified with vitamin D. ANSES considers that identifying cholecalciferol as an ED on food product labelling (or other equivalent sources of information) would contribute to an incorrect perception of the risk and could deter some people from consuming foods containing vitamin D. Such labelling could therefore make it harder to meet adequate nutritional requirements for vitamin D.

The French authorities would have to take into account this opinion before any publication of the final text.