Regulatory & compliance expertise to ensure your product succeeds in local and global markets
Cosmetic formulation, manufacturing and marketing are becoming increasingly regulated globally.
Shieling Laboratories have considerable in-house regulatory & compliance expertise to facilitate your success in local and global markets. Some important considerations are:
NZ Regulatory Environment
Formulation and labelling of cosmetics is relatively light-handed in NZ and generally follows the European model through the Cosmetic Group Standard 2012. We assist our customers in meeting the requirements for the local market.
European Regulatory Environment
The formulation, manufacture, labelling and marketing of cosmetics in the EU are overseen by the regulation EU 1223/2009 which is subject to continuous revision. This regulation is much more prescriptive and bureaucratic than what we have in NZ. Our regulatory experts assist our customers in developing approved formulations and providing the testing and documentation to get your product registered.
Rest of the World
Asian, Middle Eastern, African and countries in the Americas (excl USA) generally follow the European model, but there are regional differences relating the halal and dual language labelling (Canada) and other cultural considerations. Japan has its own set of ingredient restrictions.
The FDA regulates cosmetics in the USA. FDA ingredient restrictions and labelling imperatives are very different to the rest of the world. We advise caution in entering this market without careful analysis because many products acceptable everywhere else may not be allowed in the USA. This is particularly applicable to sunscreens, anti-perspirants, whitening products, anti-bacterials, anti-acne products and anti-dandruff shampoos. These products are all treated as medicines in the USA.
The most complex regulatory provisions globally relate to sunscreens. The USA and Australia have their own unique approaches that are out-of-step with global practises. We can advise on the best way to approach these products for these jurisdictions and other markets.