Compliance Monitoring Package
About ongoing compliance
Whether it’s the GB Cosmetics Regulation, EU Cosmetics Regulation No. 1223/2009 or the FDA FD&C Act, the requirements of the legislation, and your obligations attached to them, never stand still. With this in mind, we offer a service to support you after launch to ensure that your formulation remains safe and compliant and can be revised in a timely manner when the need arises. Additionally, we’ll also help you handle adverse reactions cases from a regulatory compliance perspective and keep your Product Information File up-to-date should anything change.
Our compliance monitoring package comprises all three services rolled into one package.
This is an annual service, although brands can opt to pay quarterly in line with the ingredient management monitoring carried out by Bloom.
What is included in the package?
Ingredient management
There are regular updates to the ingredients that can be used in cosmetic products. With impacts coming from different regulations such as the EU Cosmetic Product Regulation, REACH Regulation, and the Classification, Labelling and Packaging (CLP) Regulation, it can be challenging to keep on top of the updates and, in particular, to act in a timely manner when something needs to change in your product. At Bloom we track all relevant regulatory updates and we utilise our extensive database to store and monitor this information.
At Bloom we are very proud of our additional expertise in ingredient management forecasting. Our team members have many years of experience working in the field of ingredient monitoring and have a deep understanding of the processes and discussions that may later lead to regulatory change.
Knowing how these changes will affect your product is very important as in some cases you might need to completely reformulate and/or create a new formulation. One of the examples is the Cyclosiloxanes (D4 and D5). For such ingredients there have been many updates from different regulations and there have been drastic restrictions to the use of these ingredients in cosmetics. At Bloom we have been tracking all of these changes for our customers and alerting them ahead of time to the potential need to reformulate (or avoid, in the case of new products).
Keeping documentation up-to-date
If there have been any changes to your product the rules require that you keep your Product Information File up-to-date. These changes can include, but are not limited to, manufacturer changes, formulation changes, packaging changes, adverse events or even RP changes. Therefore, an annual audit of any changes made to your product is important in order to be compliant in case of authority checks. With regular updates, you can also streamline the product registration process through easy access to information when entering new markets.
Monitoring adverse reactions
Once a product is introduced to the market, it is possible that consumers may find that your formula is not suitable for them. This does not mean that your product is unsafe but it is not uncommon for consumers to have existing allergies or sensitivities that may be triggered by using your product. If the consumer contacts you about this occurrence, the data must be stored, monitored and, in some cases, reported to the authorities. Monitoring also enables you to identify potential safety issues and take corrective action when necessary. We will help you to process and monitor such consumer feedback.
This is an annual service which is invoiced on a quarterly basis. Each quarter we will run the monitoring of your formulas and support you through any adverse reaction cases you encounter relating to the specific product. At the end of your fourth quarter, we will check with you/your manufacturer for any updates required to the Product Information File.
The service runs on a ‘per product’ basis where each subscription will cover all sizes of the same product.
How does it work?
Not included in this service
The service includes support for adverse reaction monitoring but does not include general customer service support such as product complaints or commercial issues (e.g. refund requests).