At Danone we are committed to our dual project for business success and social progress and to lead the alimentation revolution. Our mission is “To Bring Health through Food to as Many People as Possible” and we do this by supporting people to adopt healthier choices and lifestyles, and by caring about the health and wellness of Danone and our Employees, of our communities and our planet, of current and future generations.
Danone has always advocated the importance of safe and adequate nutrition for infants by supporting and encouraging breast-feeding as the best start in life. Danone aims to provide support for each stage of an infant’s development. This includes nutritional guidance through education and services as well as high quality and nutritious age appropriate foods.
As a leader in the early life nutrition industry, we have a key role to play in both promoting and initiating change, including the area of responsible and ethical Marketing practices towards mothers, caregivers and Health Workers.
Danone acknowledges the importance of, and commits to the principles of, the International Code of Marketing of Breast-Milk Substitutes adopted on 21st May 1981 (the “WHO Code”) and the subsequent relevant resolutions of the World Health Assembly (“WHA”).
To aid in transparency, throughout this BMS Policy, references to the relevant WHO Code articles are shown down the right-hand side alongside the corresponding clauses in the Policy.
This is Danone’s Policy for the Marketing of Breast-Milk Substitutes. The WHO Code forms the basis for this BMS Policy.
The intention of this BMS Policy IS NOT to interpret or replace the WHO Code, but to provide instructions and guidance when undertaking Marketing activities on Breast-Milk Substitutes.
WHO CODE ARTICLE 1
This BMS Policy supports Danone’s mission “to bring health through food to as many people as possible”. It does this by ensuring Danone contributes to the provision of safe and adequate nutrition for infants, by protecting and promoting breast-feeding, and by ensuring the proper use of Breast-Milk Substitutes, when these are necessary, on the basis of adequate information and through appropriate Marketing and distribution practices.
As a company, it is important that we are consistent, clear and transparent as to the standards of behaviour we expect from our Employees and Partners in the performance of their duties. This BMS Policy was developed for this purpose. It details areas where Employees and Partners need to make responsible and ethical decisions related to the Marketing of foods for infants. This BMS Policy clarifies the minimum standards of behaviour that are expected of Danone Employees and Partners.
For interaction with HCOs and Health Workers (such as, without limitation, event support, contracting HCPs, donations to HCOs etc) please refer to the Danone Health Care Systems Policy for additional requirements and processes applicable to all of the Danone businesses.
The Marketing of Breast-Milk Substitutes is subject to relevant local laws and regulations or government-issued codes; this BMS Policy is not a substitute for such laws and regulations. Where local laws and regulations for implementing the WHO Code are more stringent than the BMS Policy, Danone follows the national measures in addition to the BMS Policy.
WHO CODE ARTICLE 2
This BMS Policy applies to Employees of all Danone Entities and to Partners involved in the Marketing, distribution, selling, education and/or governance of Covered Products. Danone ensures Partners understand and are made aware of the importance of abiding by this BMS Policy during all collaborations with, or on behalf of, Danone.
This BMS Policy applies worldwide to the Marketing of Covered Products.
Covered Products include:
For countries defined as Higher Risk Countries (see Appendix 1) Covered Products are extended to include:
All products listed above are further referred to as “Covered Products” throughout this document.
This BMS Policy does not apply to Excluded Products:
Excluded Products are all products, other than Covered Products, produced or sold by Danone, including products intended for use by infants with special medical conditions. These infants have limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete breast-milk or certain nutrients contained therein or metabolites, or other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet alone. These products are specially formulated to be compositionally distinct from Infant Formula intended for healthy infants.
WHO CODE ARTICLE 3
Definitions can be found in Appendix 2.
The WHO Code is a set of recommendations relating to the Marketing of Breast-Milk Substitutes, feeding bottles and teats.
The 34th session of the WHA, as the managerial body of the World Health Organisation, adopted the WHO Code as a minimum requirement to protect and promote appropriate infant and young child feeding. It was created in response to poor infant feeding practices that negatively affected the growth, health and development of children, and which were a major cause of mortality in infants and young children. The WHO Code is meant to represent the collective will of governments to ensure the protection and promotion of optimal feeding for infants and young children.
The aim of the WHO Code is to contribute to the provision of safe and adequate nutrition for infants, through:
a) The protection and promotion of breast-feeding; and
b) Ensuring the proper use of Breast-Milk Substitutes, when these are necessary, on the basis of adequate information and through appropriate Marketing and distribution practices.
The WHO Code recognises the importance of breast-feeding as the best form of nutrition for the healthy growth and development of infants. The WHO Code acknowledges that when mothers do not breast-feed, or only partially do so, there is a legitimate market for Infant Formula. Infant Formula should be available when needed, but should not be marketed or distributed in ways that may interfere with the protection and promotion of breast-feeding.
To whom is the WHO-Code addressed?
All parties should cooperate to promote the aims of the WHO Code and its implementation. The WHO Code calls on governments to take action appropriate to their social and legislative framework, and their overall development objectives, to give effect to the principles and aim of the WHO-Code, including the enactment of legislation, regulation or other suitable measures.
Pursuant to this BMS Policy, Danone commits to the following guiding principles:
1 We acknowledge national health and dietary recommendations that may recommend the introduction of safe and appropriate Complementary Foods after 4 months of age. Countries that are considered Low Risk may market Complementary Foods in line with such dietary guidelines; however, such products are always positioned as a complement to breast-milk and are never promoted to the detriment of breast-feeding.
WHO CODE ARTICLE 4.1
WHO CODE ARTICLE 4.2
“Breast-feeding is the best form of nutrition for babies and provides many benefits to babies and mothers. It is important that, in preparation for and during breast-feeding, you eat a healthy, balanced diet. Combined breast and bottle-feeding in the first weeks of life may reduce the supply of your own breast-milk, and reversing the decision not to breast-feed is difficult. Always consult your Healthcare Professional for advice about feeding your baby. If you use infant formula, you should follow manufacturer’s instructions for use carefully.”
In addition to 2.2.1 the following should also be included “The social and financial implications of using infant formula should be considered. Improper use of an infant formula or inappropriate foods or feeding methods may present a health hazard. If you use infant formula, you should follow the manufacturer’s instructions for use carefully – failure to follow the instructions may make your baby ill.”
Such materials do not use pictures or text elements which idealise the use of Covered Products.
WHO CODE ARTICLE 4.3
WHO CODE ARTICLE 5.1
WHO CODE ARTICLE 5.2
WHO CODE ARTICLE 5.3
Such practices include but are not limited to:
This provision does not restrict the establishment of pricing policies and practices intended to provide products at lower prices on a long-term basis.
WHO CODE ARTICLE 5.4
WHO CODE ARTICLE 5.5
WHO CODE ARTICLE 6.2
WHO CODE ARTICLE 6.3
WHO CODE ARTICLE 6.4
WHO CODE ARTICLE 6.5
WHO CODE ARTICLE 6.8
WHO CODE ARTICLE 7.1
WHO CODE ARTICLE 7.2
WHO CODE ARTICLE 7.3
WHO CODE ARTICLE 7.3
WHO CODE ARTICLE 7.4
WHO CODE ARTICLE 6.6
WHO CODE ARTICLE 8.1
WHO CODE ARTICLE 8.2
WHO CODE ARTICLE 9.1
WHO CODE ARTICLE 9.2
Such Labels should not have pictures of infants, nor should they have other pictures or text which may idealise the use of Infant Formula. The terms "humanised", "maternalised" or similar terms should not be used.
WHO CODE ARTICLE 9.3
WHO CODE ARTICLE 9.4
WHA Resolution 63.23
WHO CODE ARTICLE 10.1
WHO CODE ARTICLE 10.2
To ensure good governance of this BMS Policy, Danone has set forth internal processes and guidelines for consistent application and implementation by all Danone Entities and its Partners, doing business within the scope of the BMS Policy, and specifically focuses on the following six key areas:
The ultimate responsibility for the implementation of this BMS Policy lies with the Chief Executive Officer (“CEO”) of Danone S.A.
The responsibility for the management, implementation and monitoring compliance with this Policy is delegated by the CEO of Danone S.A. to the Executive Vice President (EVP) of Specialized Nutrition (“SN”) which includes the Early Life Nutrition (“ELN”) Division – who is a member of the Danone Executive Committee (“COMEX”), and who delegates day-to-day responsibility for implementation and monitoring of this BMS Policy in the CBUs to the GMs.
The Early Life Product Compliance Committee (“EL PCC”) is responsible for the global monitoring and reporting of the implementation of the BMS Policy. The membership of the EL PCC includes (but is not limited to) the following persons:
Danone reserves the right to change membership of the EL PCC from time to time, but such membership will always respect the importance of the responsibilities assigned to it.
The General Counsel SN is responsible for the global implementation and monitoring of the procedures outlined in this BMS Policy.
Whilst this BMS Policy is defined at ELN WBU level, country specific legislation, guidelines or practices, when stricter, must also be respected. Therefore, the GM of each Country Business Unit (“CBU”) is responsible for the local implementation and monitoring of the procedures of this Policy in her/his geography/ies, including ensuring that appropriate procedures and approval processes are in place.
In each Cluster, the General Secretary makes a recommendation to the General Counsel SN for the appointment of the BMS Compliance Manager(s) (“BMS-CM”). The BMS-CM is always a member of the General Secretary organisation. The General Counsel SN approves the list of BMS-CMs and any changes thereto. The BMS-CM may, when appropriate, be the Healthcare Systems Compliance Manager (“HCM”) or someone else within the General Secretary organisation.
The BMS–CM is responsible for advising on, and supporting of, the application of this BMS Policy in her/his geography through the adoption of appropriate procedures, country manual, provision of trainings, monitoring and internal reporting of any non-compliance.
A process is in place to ensure that Danone Employees responsible for the Marketing, distribution, selling, education and/or governance of Covered Products, understand the aims and principles of our BMS Policy, and their individual responsibilities in adhering to it.
The Employment Contract or letter of appointment (or local equivalent) of Danone Employees responsible for the Marketing, distribution, selling, education and/or governance of Covered Products, includes the following commitments:
The responsibility for ensuring the Employment Contracts of all Employees involved in the Marketing, distribution, selling, education and/or governance of Covered Products, include the commitments noted above, resides with the Human Resources Department of the CBU.
The Human Resources Department of the CBU will report annually to the Vice President of Human Resources on the number of Employment Contracts concluded in the previous year, which include the commitment statement noted above.
All Danone Employees involved in the Marketing, distribution, selling, education and/or governance of Covered Product receive relevant and regular training, which includes:
Training is conducted initially on commencement of employment, and at regular intervals thereafter.
The responsibility for ensuring that training is conducted and that training records are maintained, resides with the Human Resources Department of the CBU. All relevant training completions will be tracked and monitored by Danone.
The Human Resources Department of the CBU will report annually to the Vice President of Human Resources on training completion of the previous year.
A comprehensive communication programme is in place to ensure all Danone Employees are aware of the BMS Policy.
The Danone Commitments to the Marketing of Breast-Milk Substitutes are clearly displayed in all Danone offices that have an early life business.
A process is in place to ensure that the BMS Policy, and the procedures outlined in this document, have been effectively implemented. Assessment and verifications conducted are aimed at ensuring that Danone:
Any non-conformance identified with the BMS Policy, is duly reported, assessed, and brought to the attention of the EL PCC, and followed up by corrective actions and improvements.
An assessment is undertaken by a business unit on its own activities. Each business unit that is involved in the early life business undertakes regular self-assessments versus pre-established criteria.
Verifications, audits and/or reviews are undertaken by an independent third party (external) or an internal Danone function that does not report to the CBU management in question, to guarantee impartiality. Verifications, audits and/or reviews can be performed by either internal or external resources.
Internal: As part of the established Internal Audit protocol of Danone, internal verifications will be conducted on business units operating within the scope of the BMS Policy. Each BMS-CM is responsible for an annual self-assessment of BMS practices within its business unit.
External: Suitably qualified, independent third party experts, are engaged to undertake external verifications, business reviews and/or audits of no less than three business units per year.
An external verification plan recommendation, which includes location, timing and extent of work to be conducted, is proposed each year by the General Counsel SN. The plan is approved by the EL PCC.
Reporting: For each external verification and/or review undertaken, a full report is prepared and discussed with the business unit. Included in the reporting is a summary of management recommendations to address any shortcomings and/or deficiencies in internal controls and processes.
A process is in place to:
The BMS-CM coordinates the implementation and monitoring compliance of the BMS Policy, at a local CBU level and is responsible for maintaining the following:
Each BMS-CM sends her/his quarterly report to the General Counsel SN.
On a bi-annual basis, the General Counsel SN reports to the EL PCC on:
It is the responsibility of the General Counsel SN to maintain a complete and accurate record of the EL PCC meeting.
On a yearly basis, a summary report is prepared by the General Counsel SN, on all matters related to management and compliance with the BMS Policy (the “BMS Annual Summary Report”), and this report is presented to the EL PCC within 8 weeks from the end of the fiscal year.
Upon the report’s approval by the EL PCC, the General Counsel SN then submits the report to the Executive Vice President (“EVP”) of Specialized Nutrition.
Upon the approval of the BMS Annual Summary Report by the EVP of Specialized Nutrition, the General Counsel SN then submits the report to the General Counsel of Danone S.A.
On an annual basis, the head of the Product Compliance Board (“PCB”) presents the findings of the BMS Annual Summary Report to the COMEX.
On an annual basis, Danone will publish a report on the management and compliance relating to the BMS Policy, such report will include:
A clear process is in place to define the handling of allegations of non-compliance with the BMS Policy and/or local laws and regulations related to the Marketing of BMS.
Allegations of non-compliance with the BMS Policy may be received through any communication means, including, but not limited to email, Danone websites, telephone or letter.
All complaints of non-compliance shall be immediately reported to the BMS-CM of the CBU.
All review actions shall be documented and the outcome recorded regardless of whether the allegation is substantiated or not. The investigation of the alleged non-compliance shall be conducted by the BMS-CM and a formal response be given to the complainant within 4 weeks. If allegations are substantiated, appropriate remediation shall be taken.
Non-compliance will be reported to the General Counsel SN on a quarterly base.
Danone does not tolerate retaliation against, or unfair treatment of, any person (including Employees) who makes in good faith, a report regarding a violation or possible violation of applicable law, or the BMS Policy or who participates in any investigation conducted internally or by a government enforcement agency.
Any alleged non-compliance with the BMS Policy shall be recorded shortly upon receipt in a specific database detailing:
On completion of the allegation review, the database will be updated with the matter details, corrective actions taken and a copy of the response to the complainant. All remediation will be tracked, and no allegation may be reported as complete, without confirmation that the corrective action has been fully implemented.
A process is in place to enable Employees and third parties to report alleged incidents of non-compliance with the BMS Policy, in a confidential and anonymous manner. The Danone Ethics Line allows Employees to report outside their normal management reporting line potential non-compliance with company policy in a way that protects them from possible negative consequences of such reporting.
Any Employee who notices or believes there has been a breach of the BMS Policy, has a responsibility to report it as soon as possible. Reporting can be via the following means:
In the event of non-compliance with the BMS Policy such non-compliance will be brought to the EL PCC. Appropriate disciplinary action will be taken, depending on the severity and regularity of the non-compliance activity. Disciplinary actions can range from a written warning to cancellation of the Employee’s bonus, termination of the employment agreement/relationship or reporting to authorities.
To succeed in Danone’s ambition of fostering the alimentation revolution, we need to engage and work in partnership with a wide range of stakeholders, including governments, regulators and legislators, civil society and others in the business environment such as peer companies. We acknowledge and support the WHO Code and subsequent relevant WHA resolutions. The Early Life Nutrition Division complies with Danone’s Global Advocacy Policy and ensures that any lobbying related to the implementation of the WHO Code adheres to these respective principles. In detail, this means:
|Angola||El Salvador||Mauritius||Solomon Islands|
|Antigua and Barbuda||Equatorial Guinea||Mexico||Somalia|
|Argentina||Eritrea||Micronesia (Federated States of)||South Africa|
|Barbados||Ghana||Namibia||Syrian Arab Republic|
|Benin||Guinea||Nicaragua||The former Yugoslav Republic of Macedonia|
|Bosnia and Herzegovina||Haiti||Niui||Tonga|
|Botswana||Honduras||Occupied Palestinian Territory||Trinidad and Tobago|
|Burkina Faso||Iran (Islamic Republic of)||Palau||Turkmenistan|
|Cambodia||Jamaica||Papua New Guinea||Uganda|
|Cape Verde||Kazakhstan||Peru||United Arab Emirates|
|Central African Republic||Kenya||Philippines||United Republic of Tanzania|
|China||Kuwait||Republic of Moldova||Uzbekistan|
|Comoros||Lao People’s Democratic Republic||Russian Federation||Venezuela (Bolivarian Republic of)|
|Cook Islands||Lesotho||Saint Kitts and Nevis||Yemen|
|Costa Rica||Liberia||Saint Lucia||Zambia|
|Côte d’Ivoire||Libyan Arab Jamahiriya||Saint Vincent and the Grenadines||Zimbabwe|
|Democratic People's Republic of Korea||Madagascar||Samoa||Senegal|
|Democratic Republic of the Congo||Malawi||Sao Tome and Principe|
Source : FTSE-Russell 2017
BMS-CM means BMS Compliance Manager in charge of Breast-Milk Substitutes related topics relevant to his or her CBU or the ELN Division (depending on his or her area or responsibility). The HCM, if appropriate, may also be the BMS-CM.
BMS Policy means Danone’s Policy for the Marketing of Breast-Milk Substitutes.
Breast-milk Substitute means any food being marketed or otherwise presented as a partial or total replacement for breast-milk, whether or not suitable for that purpose.
Complementary Food means any food suitable as a complement to breast-milk or to Infant Formula or Follow-on Formula when either becomes insufficient to satisfy the nutritional requirements of the infant. Complementary Foods are not considered to be Breast-Milk Substitutes if they are not marketed as such but are intended to and are marketed to complement, rather than replace, breast-milk or Infant Formula.
CBU means Country Business Unit.
CEO means Chief Executive Officer
Cluster means a grouping of CBUs within a particular pre-defined geography.
COMEX means Danone Executive Committee.
Company Policies means all relevant corporate and local policies of Danone Entities.
Covered Product means:
Additionally, for Higher Risk Countries:
Donation mean financial or in-kind contribution to reflect Danone’s social responsibility and help institutions in areas other than research, science or education.
Distributor means a legal entity external to Danone, in the public or private sector, who is warehousing, distributing/reselling Danone’s products to their own customers (sub-distributors, retailers, pharmacies, hospitals). Distributors may provide a wide range of services including importing, promoting/Marketing Covered Products, medical sales, key account management, and participation in tenders on Danone’s behalf.
EL PCC means Early Life Product Compliance Committee.
ELN means Early Life Nutrition.
EVP means Executive Vice President.
Employee means any person employed under a permanent or temporary contract or at-will employment with a Danone Entity. For purposes of this BMS Policy, Employee does not include individuals providing services as a consultant or independent contractor or individuals who are employed by another entity, such as agency workers.
Entity means an entity over which Danone has operational control.
Excluded Products are those products produced by Danone and intended for use by infants with special medical conditions. These infants have limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete breast-milk or certain nutrients contained therein or metabolites, or other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet alone. These products are specially formulated to be compositionally distinct from Infant Formula intended for healthy infants.
Follow-on Formula means, for the purpose of this BMS Policy, a formula product intended for, and marketed for, infants from six to twelve months of age.
General Counsel SN means the General Counsel Specialized Nutrition, who may delegate the whole or part of her/his responsibilities under the BMS Policy to appropriate individual(s) within the SN Legal & Compliance organisation.
GM means a General Manager (of a CBU).
Grants are financial or in-kind contributions to an institution in the HCS to support scientific research, advancement of science and education, or patient or public education in relation to Covered Products.
HCM means an HCS Compliance Manager in charge of Healthcare Systems (including Breast-Milk Substitutes) related topics relevant to his or her CBU, Cluster or the ELN Division (depending on his or her area or responsibility).
Health Care Organisation (HCO) means any legal person (i) that is a health care, medical or scientific association or organisation (irrespective of the legal or organisational form) such as a hospital, clinic, foundation, university or other teaching institution or learned society (except for Patient Organisations) or (ii) through which one or more Health Worker/s provide services. This could include, for the purposes of this document, for example midwife associations. Pharmacies are not included in the definition of HCO for the purpose of this Policy.
Healthcare Professional (HCP) means any individual who practices a medical, dental, pharmaceutical, midwifery, dietetic, nutritional or nursing profession or any other person who, in the course of his or her professional activities may prescribe, or purchase, supply, recommend or administer on behalf of a patient, a nutritional product, or provide health care services.
Health Worker means a person providing health services in a HCO, whether professional or non-professional, including but not limited to, HCPs, voluntary, unpaid workers.
Higher Risk Countries means those countries that meet either of the following criteria:
A list of Higher Risk Countries is included in Appendix 1.
Health Care System (HCS) means the Health Care System that includes HCPs, HCOs and POs.
Infant Formula means a Breast-Milk Substitute formulated industrially in accordance with applicable standards, laws and regulations (including Codex Alimentarius Standards, where applicable), to satisfy the normal nutritional requirements of infants up to six months of age, and adapted to their physiological characteristics. Infant Formula may also be prepared at home in which case it is described as “home-prepared”.
Informational and/or Educational Material means any material, whether written, aural, or visual, that provides information about such topics as nutrition, health care, or growth and development of infants, but that is not intended to promote a specific brand of a product.
Label means any written or graphic material printed, marked, embossed or impressed upon or attached to the packaging of a product.
Marketing means product promotion, distribution, selling, advertising, product public relations, and information services.
Marketing Material means any material, whether written, aural, or visual, related to the sale or purchase of a specific brand of product including, but not limited to, point-of-sale advertising, special displays, Labels, television, radio, internet, social media and print advertisements.
Partners means any party acting on behalf of Danone, or in collaboration with Danone, regarding Covered Products with whom Danone has a contractual relationship, including but not limited to Distributors, agencies and HCOs.
PCB means Product Compliance Board.
PO means “Patient Organisation” which is a not-for-profit organisation (including the umbrella organisations to which they belong) mainly composed of patients and/or caregivers, that represent and/or support the needs or interests of patients and/or caregivers.
Product for Professional Evaluation (PPE) means Covered Product provided to a HCP for the purposes of professional evaluation or research at an institutional level. PPE is not considered as a Sample.
Sample means single or small quantities of a product provided at no cost to the Health Care Professional and is not intended for sale.
SN means Specialized Nutrition, which includes both the ELN and Advanced Medical Nutrition (AMN) division.
WHA means World Health Assembly.
WHO Code means International Code of Marketing of Breast Milk Substitutes of the World Health Organisation.