ISO 22716 and cosmetics exports – what do you need to know before entering foreign markets?

You have a finished product, a refined formula and the ambition to expand beyond the Polish market. Initial discussions with potential foreign partners are going well – until the question of GMP certification comes up. The lack of this document doesn’t end the conversation immediately, but it certainly puts a damper on it. In the cosmetics industry, exports and ISO 22716 certification are inextricably linked – and the sooner a company understands this, the less time and money it will waste on a dead end.

Why do export requirements differ from those in Poland?

The Polish market operates within the framework of EU regulations – Regulation (EC) No 1223/2009 sets out the requirements for cosmetics placed on the market in the EU and explicitly refers to the ISO 22716 standard as the basis for Good Manufacturing Practice. In practice, this means that a company manufacturing and selling cosmetics exclusively in Poland can technically operate without a certificate – although it is becoming increasingly difficult to secure serious business partners without one.

Outside the European Union, the situation is different. Many countries have their own systems for regulating the import of cosmetics and their own requirements for foreign manufacturers. A GMP certificate – whether ISO 22716, compliant with ASEAN GMP guidelines or other local standards – is often a prerequisite not for negotiation, but for product registration. Without it, a cosmetic product simply cannot be legally placed on the market.

Specific markets, specific requirements

The Gulf States – Saudi Arabia, the United Arab Emirates and Kuwait – require cosmetics manufacturers to hold a GMP certificate as a condition for product registration within the local SASO or GSO system. This market is particularly attractive to European brands, but entering it without GMP documentation means the entire registration process is blocked at the application stage.

In ASEAN countries – Indonesia, Thailand, Malaysia, Vietnam – the regional ASEAN Cosmetic GMP standard applies, which is directly aligned with ISO 22716. Local regulatory agencies require foreign suppliers to comply with it, and verification takes place during inspections or on the basis of a certificate issued by an accredited body.

The Australian and New Zealand markets, on the other hand, do not require formal GMP certification as a condition for import, but local distributors and retail chains treat the certificate as an industry standard and ask for it as early as the initial commercial discussions. The lack of a certificate does not legally block access – but in practice it excludes you from more serious discussions.

What should a company prepare before taking its first step into exporting?

Exporting cosmetics is not just a matter of certification – but certification is often the one thing on which everything depends. Companies planning to expand abroad should check three things before their first business negotiations.

Firstly – whether their production documentation is complete and up to date. Foreign regulatory bodies and trading partners will request detailed information regarding the production process, quality control results and batch traceability. A company without well-organised documentation is unable to provide this information efficiently.

Secondly – whether the ISO 22716 certificate they hold has been issued by a body that is accredited and recognised in the target market. Not all certificates are equal in the eyes of foreign regulators – it is worth checking this before the certificate is rejected at the registration stage.

Thirdly – does the company understand the regulatory specifics of the target market? Requirements in Saudi Arabia differ from those in Indonesia, and these in turn differ from those in Australia. A good certification advisor will not only help you obtain the certificate but also tailor the documentation to the specific target market.

Certification as an investment, not an entry cost

Companies that treat ISO 22716 certification as a one-off cost to tick off before exporting usually return after a few months asking why the certificate hasn’t opened the doors it was supposed to. This is because a certificate is a document confirming a functioning system – not a substitute for the system itself.

Companies that reverse this order – first building the system, then certifying it, then exporting – have a much shorter and cheaper path to their first foreign contract. The certificate works for them in every market simultaneously, because it says the same thing in every language: production is controlled, repeatable and verifiable by an independent third party.