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Law No. 207 Of 8 November 2016 On The Regulation Of Marketing Of Breast Milk Substitutes

Original Language Title: LEGE nr. 207 din 8 noiembrie 2016 privind reglementarea marketingului înlocuitorilor laptelui matern

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LEGE no. 207 207 of 8 November 2016 on regulating the marketing of breast milk substitutes
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 910 910 of 11 November 2016



The Romanian Parliament adopts this law + Chapter I General provisions + Article 1 (1) The present law regulates the legal framework regarding the marketing of breast milk substitutes, as well as its related practices. (. This law shall apply to the following products, hereinafter referred to as products concerned: a) substitutes for breast milk, intended for infants and children up to 2 years of age; b) any liquid, semi-solid or solid food intended for the administration of infants during the first 6 months of life or fortifying of breast milk; c) bottles, tetins, pacifiers, special cups for infants, artificial nipples, milking pumps or similar utensils; d) any other similar products. + Article 2 This law is based on the principles of the International Marketing Code of breast milk substitutes, adopted at the 34th edition of the World Health Assembly by Resolution no. 34.22 34.22 of 21 May 1981. + Article 3 The objective of this law is to create the legal framework necessary to ensure adequate and healthy nutrition for infants and children up to 2 years, through the protection and promotion of breastfeeding, in order to maintain or improve the state of health of these, by ensuring the correct use of breast milk substitutes, when they are necessary, by regulating their marketing and by providing consistent, objective and accessible information in an appropriate form the public. + Article 4 Within the meaning of the present law, the following terms and expressions have the following meanings: a) breastfeeding-feeding the child only with breast milk; b) breastfeeding on request-feeding the child with breast milk whenever he manifests his desire to be fed; c) complementary food-any food produced industrially in accordance with the national and European legislation in force, which may be used as a supplement, in addition to breast milk or infant formulae, when they no longer sufficiently satisfy the nutritional requirements of the infant or the child up to 2 years of age; d) packaging-any form of packaging of the products concerned for the purpose of sale in the form of a single package marketed, including by simple coating; e) component of the health system-any public or private institution or governmental or non-governmental organization that is part of the health system; f) distributor-any natural or legal person, from the public or private sector, engaged in activities, direct or indirect, of wholesale or retail trade of the products concerned; g) the substitutes of breast milk-any food, manufactured industrially, in accordance with the national or European legislation in force, or prepared in the domestic environment, which is marketed or presented in any other way, as a replacement partial or total breast milk, intended for the nutrition of infants or children up to 2 years of age; h) marketing-promotion, distribution, sale of the product, advertising for the product, as well as advertising, information services and relations with the public related to the product; i) family member-husband, relative to the second degree or relative of the husband to the second degree; j) sample-a single product or a small quantity of a product offered free of charge; k) marketing staff-any person whose functions involve the marketing of a product or products covered by this Law; l) staff in the health system-any person, whether specialized or not, working in a component of the health system, including persons who carry out voluntary activities or other types of activities unremunerated within these components; m) placement of the products concerned-any form of audiovisual commercial communication consisting in the inclusion of a product, of services or of their marks or reference thereto, by insertion within a program, in exchange for a payment or Counterclaims; n) producer-any natural or legal person in the public or private sector, involved in the realization/manufacture of the products concerned directly or indirectly through an agent or through another natural or legal person coordinated or controlled by this, or having a contract with it; o) promotion-communication or recommendation made in any way, commercial activity or any other action, including advertising, which aims, result or result potentially determining or encouraging the public or a person to buy either use a product or increase the demand or consumption of a product, directly or indirectly; p) advertising-advertising carried out in various ways: press or other written publications, television, broadcasting, information society services, internet, electronic transmission, video, audio or telephone, exhibitions, stands, verbal presentations, correspondence, images, posters, posters, panels, leaflets, any kind of display structures, travel tickets for public transport and any other similar modalities; q) reserves-quantities of a product offered for use for a certain duration, free of charge or at a reduced price, for social purposes; r) health system-the totality of public or private institutions or organizations, governmental or non-governmental, regardless of their degree of subordination, involved, directly or indirectly, in the protection of the health of pregnant women, mothers, infants or children up to 2 years of age. This definition also includes staff employed in private practice in the field of health and excludes pharmacies, drugstores and other similar establishments in which the targeted products are for sale. + Chapter II Information and education + Article 5 (1) The Ministry of Health, through the institutions subordinated, under the authority and/or in its coordination, has the responsibility of informing the public regarding the nutrition of infants and children up to 2 years of age. (2) The responsibility concerns the planning, elaboration, provision and dissemination of information, and the control of these activities. + Article 6 (1) The informational and educational materials relating to the nutrition of infants or children up to 2 years of age, written, auditory or visual, must include clear, detailed and correct information on: a) mother's nutrition and preparation for breastfeeding, as well as continuation of breastfeeding; b) the advantages and superiority of breastfeeding; c) disadvantages of replacement of breastfeeding and possible risks; d) the negative effect on breastfeeding through the use of the bottle in complementary nutrition; e) the difficulty of returning to the decision not to breastfeed; f) the importance of starting breastfeeding as early as possible, the importance of exclusive breastfeeding up to the age of 6 months and the importance of continuing breastfeeding until the age of 2 years; g) cases in which the use of breast milk substitutes is necessary: children to whom breastfeeding is contraindicated by the doctor, mothers who present the contraindication to breastfeed, children whose mother has died and adopted children; h) the social and financial implications of the use of breast milk substitutes, in the cases referred to in lett. g), the risks of inappropriate use of food or food methods on health, and, in particular, the risks of the use of formulas or substitutes that are not necessary or appropriate for health. These materials must not use drawings or texts to idealize the use of breast milk substitutes. (2) The informational and educational materials provided in par. (1) must be endorsed by the Ministry of Health within 30 days from the date of receipt of the related documentation. If the Ministry of Health considers it necessary to consult specialists from other institutions-research institutes, universities, other ministries-this term can be extended by another 30 days, in order to ensure the elaboration of a properly documented opinion. + Article 7 Information campaigns, as well as any information and educational actions used for the purpose of educating and informing the population regarding the nutrition of infants or children up to 2 years of age can be organized and carried out only with the opinion of the Ministry of Health, which has the right to prohibit them when the legal provisions are violated. + Chapter III Measures concerning the public, pregnant women and mothers of infants or children up to 2 years of age + Article 8 Placement, advertising and any other form of promotion of targeted products to the general public are prohibited. + Article 9 (1) It is prohibited for producers or distributors to carry out advertising or placement activities of the products covered by the sales points/structures, as well as any actions to promote the products concerned at the retail level or other activities regarding special offers, discount coupons, advertising lotteries, special sales, related sales, prizes, gifts, promotional packages, special displays on sale, distribution of samples or any other similar practices. (2) It is forbidden to carry out advertising activities and any other actions to promote the products concerned both by direct sellers and on the occasion of the distance sale of products. ((3) Provisions of para. ((1) and (2) do not restrict pricing policies and practices which aim at low-priced sales of the products concerned. ((4) By way of derogation from provisions Government Ordinance no. 99/2000 on the marketing of market products and services, republished, with subsequent amendments and completions, low-price sales cannot be preceded or accompanied by advertising. (5) Price reductions as well as any other commercial or pricing policies or practices may not be used by producers or distributors as a mechanism for advertising or promoting the products concerned. + Article 10 It shall be prohibited to offer, distribute or supply samples of products concerned or gifts to promote the products concerned or to advertise them, by producers or distributors, directly or indirectly, to the general public, pregnant women, mothers of infants or children up to 2 years of age or their family members or health care workers. + Article 11 The marketing staff, in the exercise of its function, has no right to contact, directly or indirectly, pregnant women, mothers of infants or children up to 2 years of age or members of their families or staff in the health system. + Chapter IV Measures under the health system + Article 12 The Ministry of Health, through the institutions subordinated, under the authority and/or in its coordination, all components of the health system and local public administration authorities are required to adopt the necessary measures to encourage, protect and promote breastfeeding as well as promote the principles of the present law. + Article 13 Institutions referred to in art. 12 are obliged to inform the staff in the health system of their responsibilities in the context of the application of this law. + Article 14 It is forbidden to use any component of the health system, as defined in art. 4 lit. r), on the occasion of medical scientific meetings or events, or of any location or premises offered by it, for the purpose of placing products, advertisements or any type of promotion of the products concerned, except for the transmission of information in compliance with art. 20 20 para. ((1). + Article 15 (1) Persons within the health system, including community assistants and health mediators, are required to train mothers or persons in the care of which infants or children are up to 2 years of age with regard to breast-feeding and/or use of targeted products ((. The trainings shall be made separately, for each individual case, and where breastfeeding is not possible, the risks due to the incorrect way of preparation or use of the products concerned shall be clearly explained. + Article 16 (1) The products concerned will not be marketed within the health system as defined in art. 4 lit. r). (2) Within the components of the health system will not be granted direct donations and direct or free transmission of products concerned, by producers or distributors, to the personnel of the health system, pregnant women, mothers of infants or children up to 2 years of age or their family members. + Article 17 (1) Low-price sales, donations, sponsorships, as well as any onerous or free-title submissions of targeted products, from producers or distributors, to the components of the health system or to the institutions social protection of the child, directly or indirectly, is only made within the limit of the need for children who cannot benefit from breast milk, in their records. (. The applicant institution shall take the necessary measures to ensure that the products concerned have been acquired in accordance with paragraph 1. (1), may be provided throughout the period in which the children concerned will need them. (3) The requesting institution has the obligation to hold documents regarding the situation of the products concerned obtained by donation, sponsorship or transmission for free of charge or free of charge, as well as supporting documents on the necessity of acquiring these products. (4) The products concerned, acquired according to par. ((1), may be used only within the respective institutions, may not be marketed and may not be distributed, donated or transmitted free of charge outside the institution. (5) Sales, donations, sponsorships or submissions for free title or free of charge, provided in par. ((1), may not be used by producers or distributors as a mechanism for advertising or promotion of the products concerned. + Article 18 (1) The samples of the products concerned may be provided to the components of the health system only at their request, within the limits of the needs for studies, research or professional evaluations at institutional level. (. The requesting institution shall have the obligation to justify the necessity of the respective samples. (3) The rules for the application of this law are to be determined the quantities necessary for studies, research or assessments required at the professional level. + Chapter V Measures for health care personnel + Article 19 Staff in the health system, especially the one whose activity is carried out in the field of nutrition of infants and children up to 2 years of age, is required to inform themselves about their responsibilities in the context of application provisions of this law + Article 20 ((1) Information relating to one or more of the products concerned, provided to health system personnel and pharmacists by manufacturers or distributors, may only be of a scientific or practical nature, for each product in part, and must be clear, thorough and accurate, demonstrated and substantiated. (2) Information provided according to par. ((1) must include the aspects referred to in art. 6 6 para. ((1) and must not suggest or induce the idea that the use of the products concerned is equivalent or superior to breastfeeding or to discourage breast-feeding. (3) The products concerned shall not be promoted and distributed on the occasion of providing the information provided in par. ((1). + Article 21 It is forbidden to use the services provided by staff paid by producers or distributors for the purpose of promoting the products concerned to pregnant or mothers. + Article 22 (1) Manufacturers or distributors will not promise, provide or grant, directly or indirectly, money or other benefits, for themselves or for another, to the health system staff to promote or advertise the products concerned. (2) The staff in the health system shall not claim or receive money or other benefits, for themselves or for another, from producers or distributors, directly or indirectly, in order to promote or advertise the products concerned. + Article 23 No donations will be granted, will not be transmitted free of charge, offered or provided samples of targeted products or gifts to promote targeted products or advertise them, to pregnant women, mothers of infants or children up to 2 years of age. years, members of their families or population, by staff in the health system, directly or indirectly, or by producers or distributors of products concerned, through it. + Article 24 Where staff in the health system receive sponsorships for study or research grants, for participation in professional conferences or for any other similar activities or other similar facilities from producers or distributors of the products concerned, shall be obliged to inform in writing the composition of the health system to which they are employed, in which they occupy a function or which is remunerated, that they benefit from one of the facilities mentioned, and the institution publishes on its own website this information and maintains them displayed time Three years. + Article 25 Staff in the health system will not disclose to unauthorized persons personal data of pregnant women, mothers of infants or children up to 2 years of age or their families, or other data that may lead to identification. to them. + Chapter VI Measures for marketing staff + Article 26 The marketing staff may not carry out remunerated activities within the components of the health system. + Article 27 Organization or conduct of information campaigns, as well as any kind of information actions of pregnant women, mothers of infants or children up to 2 years of age or population, in terms of nutrition of infants or children of age up to 2 years, by marketing staff is allowed only in compliance with the provisions of art. 7. + Chapter VII Labelling + Article 28 The labels of the products concerned must contain all information established according to the legal provisions in force. + Article 29 The packaging of the products concerned or their labels shall contain the following particulars: a) the "Very important" warning; b) the mention "Breast milk is the best food for your child"; c) the words "It is recommended to breast-feed exclusively with breast milk for infants up to 6 months of age"; d) a reference to the fact that the products concerned must be used only at the indication of the doctor or through the nurse and only after the mother's instruction on their use, in the case of the products concerned intended for the nutrition of infants or children up to 2 years of age; e) instructions for the proper preparation and use of the products concerned; f) warnings about the health risks arising from the storage, preparation and improper use of the products concerned; g) the age at which the product is recommended, as well as particulars allowing consumers to make a clear distinction between these products, in the case of products intended for the nutrition of infants or children up to 2 years of age; h) product composition. + Article 30 (1) All the entries on the label or packaging must be written in Romanian, without excluding their presentation in other languages, marked visibly, legibly, easily understood and in a way that does not allow deletion. It is not inscribed in obscure places or interrupted by inscriptions or images. ((2) The packaging and labelling of the products concerned will not contain images, texts or other elements likely to idealise the use of the products concerned, to encourage their use, to suggest or to induce the idea that their use is equivalent or breast-feeding or discouraging breast-feeding. (3) It is forbidden to use on the packaging and label of the products concerned of photographs or images of infants or children. (4) Graphic representations may be included to facilitate the identification or description of the product or to illustrate the methods of preparation or use of the products concerned. (5) The packaging and labelling of the products concerned may not contain the terms "humanized", "maternity" or other similar terms, which could induce the idea that the intended products intended for the nutrition of infants or children up to 2 years of age are equivalent Breast milk. + Article 31 Any other accompanying material of the product concerned as well as any information material relating to the product or its preparation and appropriate use shall contain the particulars referred to in art. 29 and comply with the conditions laid down in art. 30. + Chapter VIII Implementation and monitoring + Article 32 The Ministry of Health is the specialized body of the central public administration that ensures the development, regulation and implementation of strategies and policies in the field of nutrition of infants and children up to 2 years, including from the field of marketing of breast milk substitutes, as well as policies for the protection and promotion of breastfeeding. + Article 33 (1) The monitoring of the application of the provisions of this law is carried out by the Ministry of Health and the National Authority (2) Within 30 days from the entry into force of this law, the Ministry of Health issues the implementing rules that are approved by Government decision. + Chapter IX Liability, contraventions and sanctions + Article 34 Violation of the provisions of this law attracts, as the case may be, criminal liability, contravention, disciplinary or civil + Article 35 (1) Failure to comply with art. 6-11 6-11, art. 14-22 14-22, art. 26-31, if they are not committed so as to constitute crimes according to the criminal law, constitute contravention and are sanctioned as follows: a) with a fine of 500 lei per 1,000 lei in case of acts committed by individuals; b) with a fine of 5,000 lei per 100,000 lei in the case of acts committed by legal entities. (2) The finding of contraventions and the application of sanctions provided in par. ((1) shall be as follows: a) for violation of art. 6 6, 7, art. 14-21 14-21, art. 27, by the authorized staff of the Ministry of Health; b) for violation of art. 8-11 8-11, art. 22, 26, art. 28-31, by the authorized staff of the National Authority for Consumer Protection. + Article 36 The provisions on contraventions shall be supplemented by the provisions Government Ordinance no. 2/2001 on the legal regime of contraventions, approved with amendments and additions by Law no. 180/2002 , with subsequent amendments and completions. + Chapter X Final provisions + Article 37 (1) The Ministry of Economy, Trade and Business Relations shall notify the European Commission of the regulations contained in this Law. (2) The products covered by this Law and which are placed on the market or labelled in accordance with the legal provisions in force may continue to be marketed after the entry into force of this Law, until the exhaustion the stocks of those products concerned. + Article 38 This law shall enter into force 6 months after its publication in the Official Gazette of Romania, Part I, except for the provisions of art. 37 37 para. (1), which takes effect 3 days after publication. * This law was adopted in compliance with the provisions Directive (EU) 2015/1.535 of the European Parliament and of the Council of 9 September 2015 on the procedure for the provision of information in the field of technical regulations and rules on information society services. This law was adopted by the Romanian Parliament under the conditions of art. 77 77 para. (2), in compliance with art. 75 75 and art. 76 76 para. (2) of the Romanian Constitution, republished.
CHAMBER OF DEPUTIES PRESIDENT
FLORIN IORDACHE
SENATE PRESIDENT
CĂLIN-CONSTANTIN-ANTON POPESCU-TARICEANU Bucharest, November 8, 2016. No. 207. -----