TABLE 3.
Amendments required to complied with the International Code of Breast‐Milk Substitutes and related regulation
| Provisions with legal measures | Ethiopian laws | Description |
|---|---|---|
| Milk products covered up to age | Not clear | The national law defined growing up milk as any food marketed and suitable for feeding young children from the age of 2 years up to 3 years of age. It appears to deregulate milk products for children between the period of 12 to 24 months. National laws that are applicable on advertisement and promotion matters does not define milk products or growing‐up milk products |
| Complementary foods covered up to age | Not clear | Contrary to the Code and WHO subsequent resolution, the Food Advertisement Directive mistook the definition of dietary supplement for complimentary food. It defined complementary food as “any foodstuff whose purpose is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, and marketed in dose form, like capsules, tablets, pills and other similar forms of liquids and powders designed to be taken in measured quantities” (Directive 33, Article 2(4)) |
| Informational/educational materials covered | No | No national law provides code‐compliant measures on these matters |
| Required information for informational/educational materials | ||
| Benefit and superiority of breastfeeding | No | No national law provides code‐compliant measures on these matters |
| Maternal nutrition and preparation for and maintenance of breastfeeding | No | No national law provides code‐compliant measures on these matters |
| Negative effect on breastfeeding or bottle‐feeding | No | No national law provides code‐compliant measures on these matters |
| Difficulty reversing the decision not to breastfeed | No | No national law provides code‐compliant measures on these matters |
| Proper use of infant formula | No | No national law provides code‐compliant measures on these matters |
| Required information for materials on breastmilk substitute | ||
| Social and financial implication | No | No national law provides code‐compliant measures on these matters |
| Health hazards of inappropriate feeding | No | No national law provides code‐compliant measures on these matters |
| Health hazards of inappropriate use | No | No national law provides code‐compliant measures on these matters |
| Prohibition of pictures/text idealizing breastmilk substitute | Partial restriction | Pictures of the infants or other pictures or texts, which may idealize the use of breastmilk products on its container and the label is banned. (See, Baby Food Control Directive 39/2016, Art 8(e).) Promotion of infant formula only through exaggerated pictures and writings about its use and relevance in the health care institution, is banned. (see Art 9(3), Food Advertisement Directive 36). However, national laws do not ban the idealize the use of breastmilk products, including through educational and informational materials. |
| Approval required for donation of company materials | No | No code related national law provides the legal basis to regulate the manner for the donations of informational or educational equipment or materials by the BMS industry. The Code requires such donation to be done at the request and with the written approval of the appropriate government authority and that no BMS proprietary name be referred but the placement of the donating company's name or logo. (Article 4.3 of ICMBS) |
| Prohibitions of promotion to the general public | ||
| Advertising | Partial restriction | The advertisement of infant formula through any advertisement dissemination means is banned. (See, Art 59(4), FAMAP 1112/2019). On the other hand, follow‐up formula and complementary food may be advertised through all advertisement means (except free sample and gift for complementary food. (See Art 10 and 12, Food Advertisement Directive 36) |
| Sales device | Some restrictions | Posting messages like “reduced price” and “clearance sale” at point of sales to advertise and promote infant formula and complementary food (but other product categories) is banned (see Art 9 ((2) and 12(5), Food Advertisement Directive). National laws prohibit no other sales device besides posting related messages. However, sales devices, including special displays, discount coupons, loss‐leaders, and tie‐in sales are not restricted for all product categories except for infant formula |
| Sample and gift, and contact with mothers | Partial restriction | Advertisement of infant formula and complementary food through giving product free samples and related gifts and articles to pregnant women, mothers of infant children, and their families are banned under the Food Advertisement Directive. (See Article 9 ((2), Article 12(5), Food Advertisement Directive.) However, Free samples and gifts of BMS, including infant formula to health care workers, are not banned. Giving free samples and related gifts and articles of follow‐up formula and growing up milk to anyone is not forbidden. Providing free associated samples and gifts and items of complementary food to the families of pregnant women, mothers of infants and young children are not banned. (See Art 9, 10, and 12, Food Advertisement Directive) |
| Prohibitions of promotion to health workers/facilities | ||
| Provision of low‐cost supplies | No | No national law provides code‐compliant measures on these matters. |
| Materials and gifts | No | Infant formula may be directly advertised to health professionals. National law only regulates the manner of direct promotion. The representatives of manufacturers or distributors may not say that BMS could replace or is superior to breastfeeding. Free samples and gifts of BMS, including infant formula to health care workers, are not banned. All the remaining BMS products can be directly promoted to health workers without any legal impediment. (See Art 9 (4), Food Advertisement Directive.) Financial support and incentives that would create conflicts of interest are not banned or regulated under the Food Advertisement Directive and other national laws |
| Required information on labels of breastmilk substitutes | ||
| Recommended age of introduction | No | No national law provides code‐compliant measures on these matters |
| Warning on pathogenic microorganisms | No | No national law provides code‐compliant measures on these matters |
| Criteria for monitoring mechanism | ||
| Mandate monitoring mechanism | No | The national and regional food safety laws give legal authorities to inspectors and other officers of EFDA and regional health regulators to monitor and enforce food safety laws, including for the marketing and promotion of BMS. No mechanism that involves all the stakeholders is established at the national level. The power to investigate non‐compliance and impose sanctions lies with individual inspectors and the EFDA and regional health regulatory authorities |
| Independent and transparent | No | |
| Free from commercial interest | No | |
| Empowered to investigate code violation | No | |
| Empowered to impose a sanction | No | |
Abbreviations: BMS, breastmilk substitute; EFDA, Ethiopian Food and Drug Administration; the Code, International Code and Monitoring of Breastmilk Substitute.