Our latest Assurance in Action podcast is the final podcast of our three-part series exploring recycle clearances in the United States and Europe. This episode focuses on recycle clearances in the EU. To learn more about recycle clearances, stream our podcast now. For more information on this topic, contact us at foodcontact.assuris@intertek.com. We’re here to help!
Speakers:
Follow us on- Intertek's Assurance In Action || Twitter || LinkedIn.
Our latest Assurance in Action podcast is the final podcast of our three-part series exploring recycle clearances in the United States and Europe. This episode focuses on recycle clearances in the EU. To learn more about recycle clearances, stream our podcast now. For more information on this topic, contact us at foodcontact.assuris@intertek.com. We’re here to help!
Speakers:
Follow us on- Intertek's Assurance In Action || Twitter || LinkedIn.
00:14 --> 01:06
Speaker 1 – Mason Myers, Manager, Recycle Notification Projects, Intertek Assuris
Hi everyone! Welcome back to the Assurance in Action podcast series, where we are hosting a special podcast series about recycle clearances. Today’s episode marks the final episode in our three-part mini-series, focusing on recycling clearances in the European Union. If you’re just joining us for today’s episode, I encourage you to take a look at our last two episodes that discuss recycle clearance in the US and how Intertek can help you conduct the Surrogate Contaminant Test (aka, the “Challenge Test”).
My name is Mason Myers. I am the Manager of Recycle Notification Projects here at Intertek, and today I’m joined with my EU colleague, Anne Sophie Moriceau, Product Safety Manager specializing in Materials, and Toxicologist and PharmD, located in our Intertek Assuris France group. Anne Sophie and I specialize in helping clients achieve recycling clearances in the EU. Thanks for being here today, Anne Sophie.
01:06 --> 01:10
Speaker 2 – Anne-Sophie Moriceau, Product Safety Manager – Materials, Intertek Assuris
Thank you, Mason. Happy to be here today.
01:10 --> 01:18
Speaker 1 – Mason Myers, Manager, Recycle Notification Projects, Intertek Assuris
So, to begin, lets start with framing the overall regulatory landscape for recycled materials in the EU? Do you think that is a good place to start?
01:18 --> 02:17
Speaker 2 – Anne-Sophie Moriceau, Product Safety Manager – Materials, Intertek Assuris
Great idea!
Starting from the top, the governing regulation for recycled plastic materials and articles intended to come into contact with foods is referred to as Commission Regulation (EU) 2022/1616. This regulation went into effect in October 2022, and repealed and replaced the previous regulation we were familiar with, which was called EU 282/2008. The scientific agency that governs this regulation is called the European Food Safety Authority (or EFSA for short).
Very briefly, EU 2022/1616 is applicable to all recycling processes as it establishes the difference between suitable technology and novel technology and creates new rules to verify the safety of a recycling process. It has a few other key features we can cover today as well.
02:17 --> 02:24
Speaker 1 – Mason Myers, Manager, Recycle Notification Projects, Intertek Assuris
Ok, exciting stuff! Can you share with our listeners how they’d go about accessing this regulation if they’d like to review it themselves?
02:24 --> 02:45
Speaker 2 – Anne-Sophie Moriceau, Product Safety Manager – Materials, Intertek Assuris
Anyone can google “EU 2022/1616” and the first link will take them to the official website that has the full regulation, and it is free to access for everyone. This website will provide access to the regulation in the various languages spoken throughout the EU.
02:45 --> 02:58
Speaker 1 – Mason Myers, Manager, Recycle Notification Projects, Intertek Assuris
Easy and free access to the regulation is always nice! Diving into this regulation, maybe we can discuss the differences between suitable and novel technology and what is applicable to each of those recycling technologies?
02:58 --> 04:59
Speaker 2 – Anne-Sophie Moriceau, Product Safety Manager – Materials, Intertek Assuris
Sure! Let's define the Suitable Technology: Article 3(1) of the regulation states that A recycling technology shall be considered suitable if it is shown to be capable of recycling waste into recycled plastic materials and articles that comply with Article 3 of Regulation (EC) No 1935/2004 and are microbiologically safe.
A suitable technology needs to meet several conditions, listed in Article 4 of the regulation. Specifically, it needs to comply with the general requirements laid down in articles 6, 7, and 8 related to characterisation of input and output, as well as decontamination efficiency requirements.
If a recycling process meets these requirements, it’s deemed “suitable,” meaning that it’s proven to remove incidental contamination to a level that is safe for the recycled resin to be used in food contact applications.
Since this regulation was released towards the end of 2022, there are only two recycling processes that currently qualify as suitable technology: mechanically recycled PET (also known as polyethylene terephthalate), and recycling from product loops which are in a closed and controlled chain. Closed-loop recycling is a manufacturing process that recycles and reuses post-consumer products to supply the material to create a new version of the same product. In a sense, closed-loop recycling sees products retain their value indefinitely. There is a handy table in Annex 1 of the recycle regulation that displays all suitable technologies and the conditions to claim this type of process.
By default, all other recycling processes and materials are considered novel technology until they meet the requirements for “suitable” technology.
04:59 --> 05:23
Speaker 1 – Mason Myers, Manager, Recycle Notification Projects, Intertek Assuris
So, what you’re saying is that if I have a mechanically recycled PET recycling process, or I’m working with a feedstock that comes from product loops which are in a closed and controlled chain – that is considered suitable technology, per this regulation. So what would you need to do to receive an authorization? And how can Intertek help recyclers apply for an authorization?
05:23 --> 06:21
Speaker 2 – Anne-Sophie Moriceau, Product Safety Manager – Materials, Intertek Assuris
Intertek can certainly help recyclers apply for an authorization for suitable technology. We offer turn-key services for these types of projects, where Intertek will collect and review all the information a recycler has available, to identify where any gaps may exist and offer suggestions and recommendations on how to close them in order to make a submission to EFSA for authorization. We can also assist with any analytical testing requirements if the recycler needs to complete testing for a submission. Once we have all the required information, we can prepare the dossier appropriate for this submission type and submit it on behalf of the recycler. Once a submission is made, EFSA may ask questions and need more information to complete their review – if this happens, Intertek will help manage the responses back to EFSA by working with the client to ensure all the information requested can be answered.
06:21 --> 06:30
Speaker 1 – Mason Myers, Manager, Recycle Notification Projects, Intertek Assuris
Wow, that’s very thorough. It’s good to know we have this capability. Any other useful information to know about the application process?
06:30 --> 07:10
Speaker 2 – Anne-Sophie Moriceau, Product Safety Manager – Materials, Intertek Assuris
Yes! Once a submission is made, EFSA can take anywhere from 6-12 months to complete the review. Once they complete the review period, they issue a Scientific Opinion that will notify a recycler that their authorization is granted, or deny the authorization and explain why.
Also worth noting, the new regulation introduced an audit requirement that must be completed by the recycler too. It’s called a Compliance Monitoring Summary Sheet (or CMSS for short) and is found in Annex II of the regulation. However, there is currently a small problem with completing this requirement.
07:10 --> 07:12
Speaker 1 – Mason Myers, Manager, Recycle Notification Projects, Intertek Assuris
What’s that?
07:12 --> 07:37
Speaker 2 – Anne-Sophie Moriceau, Product Safety Manager – Materials, Intertek Assuris
Well, EFSA has published instructions on how to conduct this CMSS requirement for any member within the EU bloc, but for all countries outside of the EU bloc, EFSA is still working out the details. Some grey areas need to be clarified by EFSA, and we are waiting for them to provide instructions on how to conduct the CMSS for recyclers outside of the EU.
07:37 --> 07:44
Speaker 1 – Mason Myers, Manager, Recycle Notification Projects, Intertek Assuris
Understood. So can Intertek still help with the CMSS?
07:44 --> 08:02
Speaker 2 – Anne-Sophie Moriceau, Product Safety Manager – Materials, Intertek Assuris
Yes, definitely. But for recyclers outside of the EU bloc, we may have to wait until further instructions are released by EFSA to learn what they expect for recyclers outside of the Bloc. A draft guidance is already available on the EC website, but we are waiting for the final version.
08:02 --> 08:13
Speaker 1 – Mason Myers, Manager, Recycle Notification Projects, Intertek Assuris
Ok—I’m sure we’re all excited to receive that update! Let’s switch over to the category of “Novel Technology” you mentioned. How does “novel technology” differ from “suitable technology”?
08:13 --> 08:40
Speaker 2 – Anne-Sophie Moriceau, Product Safety Manager – Materials, Intertek Assuris
If the technology and material is not mechanically recycled PET or feedstock that comes from product loops in a closed and controlled chain, it automatically falls into the novel technology category. This means it is yet to be proven that the technology, the material, or the combination of them can generate final recycled resins that are safe and suitable for food contact applications.
08:40 --> 08:42
Speaker 1 – Mason Myers, Manager, Recycle Notification Projects, Intertek Assuris
So what would this mean for a recycler?
08:42 --> 08:55
Speaker 2 – Anne-Sophie Moriceau, Product Safety Manager – Materials, Intertek Assuris
It means that they would need to show enough evidence to prove that the recycling technology and material meets all of the conditions for generating recycled material that is safe for food applications.
08:55 --> 08:58
Speaker 1 – Mason Myers, Manager, Recycle Notification Projects, Intertek Assuris
And how would they go about doing that?
08:58 --> 11:28
Speaker 2 – Anne-Sophie Moriceau, Product Safety Manager – Materials, Intertek Assuris
Well, similar to suitable technology, Intertek offers turn-key solutions for novel technology submissions as well.
There are more steps, tests, and communications to EFSA involved for a novel technology submission compared to a suitable technology. For instance, the first condition that needs to be met is preparing the Notification (which is Article 10 in the regulation). In this step, Intertek can review the recycler’s existing information and data to notify them what additional information and data they’ll need to be successful at this step. A request must then be sent to EFSA notifying them of the suggested testing strategy that will be used to generate the necessary data to be added to the EU Register and to prepare a dossier package for a “light” submission. I say “light” because this is the first of two dossiers that must be submitted to EFSA for a novel technology.
The “light” dossier is then submitted to a Member State for review, which can take up to 5 months for feedback. If the response is positive, we move forward with the next phase. At this stage, the applicant can enter their materials into the EU market while they collect data to prove this novel technology and material is safe for food contact applications. For a minimum of two years, the recycler will be required to conduct the tests referenced in the “light” submission and publish those results on their own website, every six months – so a total of 4 updates are required. Once the applicant has met the data requirements, they can submit all of the generated data in the next dossier for review. This time, the dossier is evaluated by EFSA and can take from 6-12 months for review, after which they will issue a Scientific Opinion on your process. If it is positive, the novel technology will now be considered a suitable technology and be added to Annex 1 Table 1 of the regulations, granting authorization. EFSA could request the recycler to generate more data for review, extending the data collection period for up to four additional years (so six years total). If the Scientific Opinion is negative, the recycler would be required to withdraw their recycled material from the EU Market.
11:28 --> 11:42
Speaker 1 – Mason Myers, Manager, Recycle Notification Projects, Intertek Assuris
Wow. It sounds like novel technology is a much longer journey towards clearance. But it’s also applicable to almost all recyclers outside of mechanically recycled PET and product loops in a closed and controlled chain.
11:42 --> 12:09
Speaker 2 – Anne-Sophie Moriceau, Product Safety Manager – Materials, Intertek Assuris
That’s correct, Mason. Here’s something else that may help recyclers out there: According to this new regulation, chemical recycling which go back to monomer itself is exempt from these requirements, as it’s popularly known that chemical recycling can purify monomers to the point that they are safe to sell back to the industry or repolymerize back into a resin for food contact applications.
12:09 --> 12:55
Speaker 1 – Mason Myers, Manager, Recycle Notification Projects, Intertek Assuris
Ok, that is much simpler than the process for novel technologies, and very useful to know!
Anne Sophie – it’s been a pleasure chatting with you today and thank you for sharing all this insight related to recycle clearances in the EU. That brings us to the close of this episode, and of this mini-series. We’d like to thank our listeners for joining us today and we hope this information proves valuable. If you have any questions related to recycling clearances, feel free to reach out to any of the experts that have joined us in this series or send us an email at foodcontact.assuris@intertek.com. We will be happy to help!
As a reminder, we’ve published two earlier episodes in this series, so do check those out if you’re just joining us for this final episode. Have a wonderful day.