Engel Hellyer & Partners is one of the most trusted and experienced Pharmaceutical TGA and AICIS Regulatory Affairs consultants.
Since 1982, we have been providing quality regulatory advice to large multinationals and SMEs.
AICIS Regulation of Industrial Chemical Products
There is no one single piece of legislation or government agency which outlines the ingredient and label requirements for industrial chemical products. Rather, at least a dozen government agencies influence some aspect of the product. Each agency administers regulations covering that agencies activities and each one does so in its own unique way.
This result of all this regulation it is easy for a non-expert to accidentally break the law by placing products on the marketplace with non-compliant ingredients or non-compliant labels. Many offences are strict-liability offences so the regulators may not be very concerned with pleas of ignorance!
What is in your product…are your ingredients compliant?
AICIS regulates the ingredients that can go into your product and a good first step is to check if your ingredients are listed on the Industrial Chemicals Inventory. If you have CAS Numbers for all your ingredients this is a good first start.
However, if you don’t have the CAS Numbers for your ingredients – you will find that searching the inventory can be a very draining experience! A single chemical may be known by dozens of different names, however only one or two names are usually listed on the inventory. Unless you are a chemicals expert it can be quite a challenge to determine if your ingredients are listed or not.
Assuming that you do find the ingredient – the next step is to investigate if the ingredient is subject to any AICIS conditions. This may or may not be difficult depending on whether or not the assessment reports are public – if they aren’t then you need to contact AICIS and converse with them to check. We also recommend checking any applicable IMAP reviews for each ingredient to determine if the regulator may be looking to propose future restrictions to any ingredients in your product!
Having assisted dozens of companies since the previous NICNAS came into operation, we have applied for and gained NICNAS approval for over 200 certificate notifications (STDs, LTDs, PLCs, SNs, EXs), almost 100 permit applications (LVCs, CEPs, EIPs) and approximately 1,000 10-100kg pa Cosmetic CE-1 Advices for Exemption under the former scheme
At the time of this writing it is early July 2020 and we have already begun assisting clients by entering Pre Introduction Reports (PIR)s under the new AICIS scheme! Whilst two years sounds like plenty of time to become compliant – the new scheme is full of unique quirks and challenges – we have already wrapped our heads around the new details so that you don’t have to!
In addition to the above you also need to ensure that your ingredients are not restricted in the Poisons Standard/SUSMP or covered by Customs Regulations and other workplace industrial chemicals regulations at the state level.
We can take on these activities on your behalf to ensure that you are fully compliant should one of the regulators decide to audit your company!
Are you supplying products to New Zealand? We can also assist you to makes sure that your products comply with NZ EPA, Inventory of Chemicals and Group Standards requirements.
Is your label compliant?
Is your product intended for consumer domestic use, or is it intended primarily for use in the workplace? The answer to this question will determine whether your label needs to comply with the Poisons Schedule administered by the Department of Health or with the GHS requirements administered by Safework Australia.
In addition, did you know that there are different government departments involved in regulating different parts of your product label? For example, the National Measurement Institute sets the rules that require you to place your product trade measure on the front and at the required font size. Whereas Australian Border Force sets the rules for country of origin labeling. Product claims are regulated by the ACCC under the Australian Consumer Law.
Certain products such as children’s toys are subject to mandatory ACCC standards. If the toys are face paints then they are classed as cosmetics with additional ingredient labelling requirements also administered by the ACCC.
There are specialised requirements for aerosols, flammable, and other dangerous goods. In some cases, there. may be additional rules regarding the storage, handling, and transport of these ingredients.
There may also be additional label requirements if your product is to be supplied to New Zealand.
All suppliers of hazardous substances are required to also provide a GHS compliant SDS downstream to their workplace customers. We can assist you with determining whether or not your product meets the hazardous criteria and we can draft Australia, New Zealand and worldwide compliant GHS.