After consultation with stakeholders and Certification bodies, APEDA has developed draft standards for Organic Cosmetics and Personal Care Products and the same were placed on the website for comments and feedback.
As per a recent notification by APEDA, the national accreditation body has approved the standards and initially these are proposed to be launched as voluntary standards without any legal restriction. The standards are being launched with immediate effect. Certification bodies interested in getting extension of their scope for accreditation of Organic Cosmetics and Personal Care Products may apply to APEDA in the prescribed form along with policy procedures, checklist and formats available on the website.
ORGANIC COSMETICS AND PERSONAL CARE PRODUCTS
Scope
Organic Cosmetics and Personal Care Products Standard prescribed under these rules refer to all cosmetics, cosmetic products, ingredients used in the manufacturing of organic cosmetics, personal care products and ingredients used in making of personal care products.
General Principles
Organic cosmetics and personal care products shall primarily consists of ingredients derived from plant, animal or microbial origin, produced, processed and handled in compliance of the standards under these rules. Natural and mineral ingredients as allowed under these rules shall be used. Synthetic ingredients (from petrochemical sources or synthetically produced through chemical reactions) shall not be used unless allowed under these standards as exceptions.
As a general rule following ingredients and processes shall be prohibited:
i) Ingredients or raw materials produced using genetically modified organisms or their by-products, derivatives or catalysts
ii) All forms of irradiation including gamma irradiation, X-rays etc
iii) Testing of cosmetics products or their ingredients on animals by manufacturer or any third party associated with the manufacturing and processing of products or its ingredients
iv) Nano-materials or ingredients made through nano-technology, except in cases where their inclusion is necessary to meet certain technological requirement, to be demonstrated by the producer and shall be subject to evaluation by accredited certification body
v) Ingredients from sources using applications of sewage sludge.
Organic Management Plan
The producer, processor or handler of organic cosmetics and personal care products shall submit an annual organic system plan (OSP). The OSP shall be updated annually. The OSP shall include following:
i) Detailed description of products, processes, processing and handling facilities, equipments, machines, storages, warehouse etc
ii) Full list of ingredients, process recipes, sources of raw materials and organic status of each and every ingredient
iii) Detailed description of up-keep, hygiene and sanitary practices, products used in sanitation and hygiene practices
iv) Detailed description of monitoring practices and process flow charts
v) Detailed description of contamination control procedures
vi) Details of record keeping to demonstrate compliance of standards and end-to-end traceability
vii) Any other information as sought by the accredited certification body
viii) In case if there is need to change or modify the OSP, the operator shall inform the ACB and obtain its approval before implementing the modified system plan.
Allowed Ingredients
i) Water – The water used in the process shall be of potable quality. Water obtained from distillation, reverse osmosis, natural springs or natural sea water can also be used.
ii) Minerals – Naturally mined minerals can be used subject to following conditions:
a. Mineral ingredients are used in their original form and shall not be subjected to chemical transformation
b. Mineral ingredients may be treated/ concentrated, extracted or modified with the physical processes listed in Annexure 1.
c. List of minerals allowed for use in organic cosmetics is given in Annex.
iii) Plant Products – Plants, plant products, processed plant products; certified organic in compliance of standards, as follows:
a. All plants and raw plant products certified organic in compliance of standards prescribed at Appendix 1, 7 and 8 of these rules.
b. All processed plant products certified organic in compliance of standards prescribed at Appendix 5 of these rules
c. Plant products not listed at iii(a) and iii(b) above but produced using the methods and processes listed in Annex 1 of this standard, provided the 95% raw material used are from certified organic sources
iv) Animal/ livestock products – Animal/ livestock products produced and processed subject to following conditions:
a. Animal/ livestock products certified organic in compliance of the standards prescribed at Appendix 2 and 3 of these rules
b. Animal/ livestock product produced using the methods allowed under Annex 1 of these standards, provided the 95% of the raw material was from certified organic sources
c. In cases where the animal product is from animals other than covered under Appendix 2 and 3 of these rules, then it is produced by the animal but not part of the animal and did not entail the death of animal concerned
v) Microbial products – Products of microbial fermentation or microbial processing are allowed provided the raw material used in fermentation comprise of plant/ animal/ mineral source and have been processed by the methods prescribed in Annex 1 of these standards
vi) Marine products – Plant products of marine origin such as sea weeds or algae etc, certified as organic in compliance of standards prescribed at Appendix 8 of these rules and their processed products produced by the methods prescribed at Annex 1 of these standards.
vii. Synthetic products – Exempted list of synthetic ingredients as preservatives, chelating agents or denaturing agents is given in Annex 4. Accredited certification bodies may allow use of certain synthetic solvents for extraction of some ingredients for which no organically acceptable alternatives are available. But in all such cases it has to be ensured that, synthetic solvents are completely removed or removed to the technologically unavoidable and technically ineffective concentrations in the finished products
Processing
Processing of organic cosmetic and personal care products should be done in natural ways using physical, mechanical and biological processes in the first stage and permitted chemical processes as listed in Annexure 3.
All ingredients, processing aids and preservatives shall be of organic origin, unless otherwise mentioned at 4 (i) to 4(vii) above
List of permitted physical processes is given at Annexure 2.
List of permitted and prohibited chemical processes is given in Annexure 3
Composition of final product and labelling claims
For a cosmetic and personal care product to be claimed as organic, made with organic or contains organic ingredients following composition norms shall apply:
i) As water, salt mined minerals including allowed processed mineral ingredients, are considered neutral ingredients, they shall be excluded from the calculation of organic ingredients
ii) Single ingredient product shall be labelled as organic
iii) Where not all ingredients are of organic origin and or are not in the list of allowed ingredients under these standards, following criteria shall apply:
a. Where a minimum of 95% of ingredients are of certified organic/ allowed substance origin, the product may be labelled as “ORGANIC”
b. Where less than 95% but not less than 70% of the ingredients are from certified organic/ allowed substances the product may not be labelled as organic but may use the term “MADE WITH ORGANIC INGREDIENTS x%”, where x denotes the percentage of organic ingredients in the final product
c. Where less than 70% of the ingredients are of certified organic , the indication that an ingredient is organic may appear in the list of ingredients and the product cannot be labelled as organic.
Storage and Transport
i) Organic products and ingredients shall be stored in a way that there is complete integrity of the product with documented traceability. Organic products shall be protected from co-mingling with non-organic products and from contact with materials and substances not permitted under these standards
ii) Storage areas and transport containers should be cleaned using methods and substances listed in Annex 5 of these standards
iii) Bulk stores for organic products and ingredients should be separate from nonorganic ingredients and clearly labelled.
Cleaning and Disinfection
i) Entire processing and handling area including all machines and tools should be maintained at high level of cleanliness
ii) All measures should be in place to ensure the integrity of organic products during the entire process and there are no chances for co-mingling with nonorganic product/ ingredients and there are no chances of contamination through contact with non-organic or prohibited substances.
iii) All machinery/ tools coming in contact with organic products should be cleaned, disinfected and rinsed with rinsing agent before and after the production of products covered under these standards.
(For Annexures please visit Apeda website)