Laboratory network to boost market access for southern Africa’s biotrade companies
The ABioSA project and its partners are facilitating the development of a laboratory network to help SMEs comply with European regulations and access EU markets for natural plant products and ingredients.
Market access is one of the major challenges for biotrade exporters into the EU, as it requires quality guarantees, regulatory compliance and assurance that products are safe for the environment and for human use such as chemical raw materials, foods, nutritional products and cosmetics.
The proposed laboratory network aims to boost confidence and trust in the quality of southern African vegetable and essential oils. The project will also support a collective REACH registration (Registration, Evaluation, Authorisation and Restriction of Chemicals) to reduce barriers to trade with the EU and make it more affordable to a larger number of small companies, while protecting their confidential information and intellectual property.
ABioSA is working with global regulatory consultancy Lisam to identify and respond to current gaps in local SME compliance. Lisam has identified local and international laboratories which can assist with testing of oils, cosmetic and food products according to EU requirements. It has contacted more than 130 local and international laboratories, of which 29 are approved as participants in the network. Ten of the laboratories are international and have indicated a willingness to collaborate with their southern African counterparts.
Lisam is also providing biotrade SMEs with technical advice on how to comply with classification, labelling and packaging of substances (EU CLP) and EU cosmetic product regulation (EC 1223/2009).
Most biotrade SMEs in Southern Africa are not familiar or fully compliant with these regulations, and don’t understand how compliance may expand their customer base.
A 2019 preliminary study by Lisam, on behalf of ABioSA, asked 30 biotrade SMEs to submit regulatory documents, laboratory reports and certificates of analyses (COA) to determine their level of compliance with the EU regulations. It found many SMEs provided missing data, or COAs not signed by the technical signatory or laboratory technician, which meant oils could not be correctly classified.
Some businesses did not provide sufficient information to confirm their oils were exempt from REACH registration, laboratory reports were supplied of tests not carried out on their own oils and some used laboratories that were not accredited or not working according to Good Laboratory Practice (GLP). In some cases, claims were made on cosmetic product labels without supporting clinical or market trials. Most SMEs did not have Product Information Files (PIFs) and safety assessments on their finished products being marketed and sold to consumers in the EU and SA.
ABioSA technical advisor
Lisam CEO South Africa