Compliance and Regulatory
Enteral Nutrition Association of South Africa (ENASA) members pledge to abide by all
local regulations in South Africa and endeavour to work closely with relevant stakeholders
within the Department of Health such as, Food Control, Nutrition Directorate, Port Health,
National Regulator, South African Health Products Regulatory Authority (previously known
as the Medicines Control Council) and Department of Agriculture, Forestry and Fisheries.
FOODS FOR SPECIAL MEDICAL PURPOSES (FSMPs)
Foods for special medical purposes are a category of foods for special dietary uses which are specially processed or formulated and presented for the dietary management of patients and may be used only under medical supervision. FSMPs are intended for the exclusive or partial feeding of patients with limited or impaired capacity to take, digest, absorb or metabolize ordinary foodstuffs or certain nutrients contained therein, or who have other special medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for special dietary uses, or by a combination of the two.
(Source: Codex Stan 180-1991)
There is currently no regulatory framework applicable to the unique requirements of foods for special medical purposes (FSMPs) in South Africa. The regulation for FSMPs is still under construction and ENASA members continue to engage with the Department of Food Control and Nutrition Directorate.
In the absence of FSMP regulations, ENASA members are requested to abide by Codex Stan 180-1991, which is an international standard which applies to the labelling of and claims for foods for special medical purposes.
REGULATIONS RELATING TO FOODSTUFFS FOR INFANTS AND YOUNG CHILDREN (R991 of 6 December 2012)
Where conflict exists between Codex Standards and Regulation 991, these regulations take precedence.
Infant formula for special medical purposes, for infants from birth to 12 months of age, fall under the scope of R991.
REGULATIONS RELATING TO MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVDs)
9 December 2016
Medical devices have been developed to simplify enteral feeding which allows nutritional treatment to be tailored to the patient’s needs.
Enteral feeding pumps and feeding sets fall under the scope of medical devices and as such, industry requires a distribution licence under the South African Health Products Regulatory Authority (SAHPRA) http://www.mccza.com/, which has officially replaced the Medicines Control Council (MCC) as per the press release issued by Ministry of Health and dated 12 February 2018.
LEGAL METROLOGY BY NATIONAL REGULATOR FOR COMPULSORY SPECIFICATIONS (NRCS) Act No. 9 of 2014
Legal Metrology in South Africa ensures that the consumer receives the quantity of goods declared by the manufacturer.
All ENASA members are to comply with the Legal Metrology Act and ensure that all enteral feeding products are registered with the NRCS and in addition, allow for annual inspection by their NRCS representative.
ANIMAL DISEASES Act No. 35 of 1984
The purpose of the Animal Disease Act is to “provide for the control of animal diseases and parasites, for measures to promote animal health, and for matters connected therewith.”
In interpreting its application to products, one therefore needs to ensure that the products being subjected to control is in fact capable of carrying animal diseases or parasites, or pose a risk to animal health in South Africa.
Section 6 of the Animal Disease Act requires a permit for the importation of “any animal… or contaminated or infectious thing”. A permit is not required for an “animal product” and the heading of the section refers to “controlled” animals from being imported.
Member companies of ENASA manufacture and import products used in enteral feeding. Enteral feeding refers to the delivery of a nutritionally complete feed, containing protein, carbohydrate, fat, water, minerals and vitamins, directly into the stomach, duodenum or jejunum.
The Enteral Nutrition Association of South Africa is working closely with the Department of Agriculture, Forestry and Fisheries to establish our position with the Animal Diseases Act.
COUNCIL FOR MEDICAL SCHEMES (CMS)
The CMS is a body which provides regulatory supervision to more than 80 registered medical schemes in South Africa. Continued work is underway to ensure that the role of medical nutrition is recognised in the management of medical conditions, with the aim to ensure adequate access for patients to optimal nutritional care.