What was the inspiration behind Deenamic?
Deenamic Ltd was founded by our director Louise McGrath back in 2019. The goal is to help organizations navigate regulation and steer their company towards success.
Since the company’s inception, we’ve gone on to open offices in both Ireland and London and grow our team. In fact, we’re looking to grow our team right now by hiring another position. You can check it out here.
We have been gaining valuable experience which translates into quality service.
What are the core services Deenamic provides?
Deenamic provide a range of services which reflect the professional interests and capabilities of our staff. Whether it be regulation regarding biocides to agrichemicals, Deenamic Ltd could be the consultancy you need.
You can find out more about the services we provide on our Services section.
What is an SDS?
A Safety Data Sheet (SDS) is the primary way for risks associated with particular chemicals to be communicated in a working environment.
Despite their obvious important, many are regularly found to be substandard in quality. In fact back in 2019 48% of SDSs were found to have something missing. This has led to greater levels of quality enforcement coming in from the European Chemical Agency in coming years. At Deenamic Ltd, our consultants are trained in ensuring that your Safety Data Sheets are up to the required professional standard.
Safety Data Sheet review is a core part of Deenamic’s work and our consultants have lots of experience in that aspect of the industry. You can read more on the emerging SDS enforcement here.
What does the biocide approval process look like?
Biocidal marketing processes occur at two levels within Europe; nationally and from the European Union.
When it comes to approving a product for sale the process can vary hugely between countries. However, there are key, salient things to keep in mind. A National Product Approval is necessary for every single nation you want to market your product to. Furthermore, separate forms need to be completed for each country. Just because your product is approved in one EU nation, does not mean it can be sold in another and so on.
There can often be significant differences in the approval processes between countries. An example of the contrast between the way different countries approved biocides would be the Spanish and French Biocide Product Approval processes.
In France, the system is online and centralized for all biocidal product types. Minimal data is required: they want the composition, substance concentration, manufacturer details, product type and an SDS.
On the other hand, the Spanish process requires more investment from the organization marketing the product. The system and department for biocide approval changes depending on the product type. Extensive data is required. This includes a specific application form, technical report including in-depth physical, chemical and toxicological data. Quality control parameters must also be clearly established.
There are three different authorisation pathways for biocides:
- Simplified authorisation – specific criteria e.g., products with no concerning substances
- National authorisation – planning to sell biocidal products in one EU Member State
- Mutual recognition – extend the national product authorisation to other markets via the recognition of the signal national authorisation
How does CLP (Classification, Labelling, Packaging) impact my business?
CLP Regulation is a crucial part of any business as incorrectly labelling products could leave consumers at risk. The main aim of CLP is to determine whether a substance or mixture displays properties that lead to a hazardous classification. Packaging requirements protect users from hazards posed by risky chemicals.
Substances or mixtures need to be labelled in accordance with CLP rules and in the official language of the Member State they are being sold in. This could include making sure labels show a product identifier, supplier details, hazard pictograms and so on.
Deenamic Ltd can curate translators, graphic designers, CLP reviewers as well as any other necessary role to ensure an organization’s compliance with CLP Regulation.
What is the “transitional period?”
The transitional period is the timeframe when a new biocidal product is waiting for the outcome of its active substance approval before it can be placed on the market under national authority of each member state. It is defined in Article 89 of Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (BPR.) The transitional periods ends when all the active substances in the product have been approved for the specific biocidal product type. At this point, EU marketing authorisation must be sought for the product to remain available on the European market, also in accordance with BPR.
How do I place a biocidal product on the EU market?
Making a biocidal product available on the market is by no means a linear process. The active substances in the biocidal product must be present on Article 95 (BPR) prior to be placed on the market. The status of these active substances greatly affects the pathway to marketing the product. Below are the three most common pathways underlined.
All active substances are approved and on Article 95
EU Marketing Authorisation must be sought to allow for the biocidal product to be made available on the market. There are three pathways to gain market authorisation:
- Simplified authorisation – specific criteria e.g., products with no concerning substances.
- National authorisation – planning to sell biocidal product in one EU Member State.
- Mutual recognition – extend the national product authorisation to other markets via the recognition of the singular national authorisation.
A lot of expertise and judgement is required for this process, along with extensive strategy depending on the future goals of the new product. This is what makes working with a company such as Deenamic Ltd so valuable.
Some or all active substances are in the review programme of Article 95
If some or all the active substances are under review, then transitional measures apply (Article 89, BPR). Until all active substances are approved, the product is in the “transitional period” (see above.) During this time, biocidal products can be placed on member state markets at the discretion of the individual national authorities. National product approval must be given before the biocidal product can be made available on that country’s market. This process differs greatly between countries, as the name of the process and the application requirements is not harmonised across the EU. Once all active substances are approved (enter Article 95,) EU Marketing Authorisation must be sought.
Active substances are not on Article 95
If the active substances are not on Article 95, then the biocidal product cannot be sold in the EU in accordance with Regulation (Eu) No 528/2012. An application for active substance approval must be made before the making available of a biocidal product on the market can proceed.
What is Article 95 of the BPR and how does it impact my business?
Article 95 of Regulation (Eu) No 528/2012 (BPR) is a list of approved active substances and suppliers of active substances found in biocidal products. This list allows for stringent control of hazardous ingredients in biocides. Furthermore, this list ascertains that compliancy costs are spread equally between suppliers and producers. If your business produces actives substances or produces products containing them, they must be active substances as present on Article 95.
What are the labelling requirements for biocides?
All substances and mixtures sold in the EU must be compliant with Regulation (EC) No 1272/2008 (CLP) before marketing. In addition to this, biocidal products have supplementary requirements outlined in Article 69 of Regulation (EU) No 528/2012 (BPR) including:
- Must state it is a biocide/biocidal product
- Present identity and concentration of every active substance
- The word ‘nano’ in brackets must follow every nanomaterial in the ingredients list, if applicable
- The authorisation number of the product given by the competent authority or EU commission
- The name and address of the authorisation holder
- The type of formulation (e.g., AE Aerosol)
- The exact uses for which the biocidal product is authorised
- Directions for use, frequency of application and dose rate for each use listed.
- Information regarding likely direct or indirect adverse side effects and any directions for first aid
- Directions for the safe disposal of the biocidal product and its packaging
- The formulation batch number or designation and the expiry date relevant to normal conditions of storage
There are additional requirements outlined in Article 69 that are only applicable in certain situations. This means a great deal of technical expertise is essential. Furthermore, each member state can enforce national requirements for the label which adds a further layer of requirements.
How long does the marketing process take?
The duration of the marketing process varies hugely based on the future plans of the product. Depending on the country, a biocidal product may be made available on the market through transitional measures in under a year. The process can take up to five years from start to finish (including EU marketing authorization.)
How often should an SDS be reviewed?
Safety data sheets (SDS’s) should ideally be reviewed every six months to ensure the data is up to date and the sheet is still compliant. Article 31 of Regulation (EC) No 1907/2006 (EU REACH) outlines the requirements for SDS’s. This regulation is constantly being updated in accordance with the Globally Harmonised System (GHS) and the safety needs of the public and environment.
SDSs are often found to be lacking in some regard, which highlights the importance of having a trained professional who can review them for you.
When was the new Medical Device Regulation (MDR) implemented?
The regulations came into force in May 2017, following their publication in the ‘Official Journal of the European Union.’ The Regulation had a staggered transitional period of 3 years, but due to the pandemic full application of the MDR has been extended and was fully applicable from 26 May 2021, However, IVDR will be fully applicable on 26 May 2022, after a five-year transition period.
On 23 April 2020 European regulatory bodies adopted Regulation 2020/561 amending application dates for Regulation (EU) 2017/745. This Regulation postponed the date of application for most Medical Devices Regulation provisions by one year – until 26 May 2021.
IVDR (In Vitro Diagnostic Medical Device Regulation), or Regulation (EU) 2017/746 of the European Parliament and of the Council is a legal act intended to establish regulatory framework in the sphere of in vitro diagnostic medical devices. The main goal of the new IVDR is to improve transparency and maintain a high level of safety for public health, establishing a balance between protecting health, and the interests of small and medium enterprises involved in medical device manufacturing. The Regulation also establishes standards applicable for these types of medical devices and general requirements for their safety and efficiency
IVDR will come into effect next year and the corresponding date of application for IVDR (Regulation (EU) 2017/746) remains in May 2022. EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 of in vitro diagnosis medical devices.
The new Regulations contain important improvements including a much larger EUDAMED database than the one that currently exists under the Medical Devices Directives.
When do medical device manufacturers need to comply with the new MDR?
The MDR was due to become fully applicable from 26 May 2020 after a three-year transitional period, however the global pandemic meant full application was postponed to 26 May 2021.
At this stage the MDR is fully in effect. EUDAMED implementation will improve the transparency and coordination of information regarding medical devices available on the EU market. The system will be multipurpose. It will function as a registration system, a collaborative system, a notification system and a dissemination system (open to the public) and will be interoperable.