Pine Needle Extract from Pinus sylvestris Officially Recognized as Non-Novel in the EU —
A Breakthrough Led by BF‑EssE
By successfully obtaining the non-new categorization for Pinus sylvestris (Scots pine) extract, BF-EssE has accomplished a unique and highly specialized regulatory accomplishment that permits its use in food and food supplements throughout the European Union without requiring novel food authorization.
More than just compliance, this result demonstrates BF Esse's scientific leadership, dedication to open innovation, and remarkable proficiency navigating intricate EU regulatory frameworks that the majority of contract manufacturers completely ignore.
We contribute to defining the rules' application rather than merely adhering to them.
More than just compliance, this result demonstrates BF Esse's scientific leadership, dedication to open innovation, and remarkable proficiency navigating intricate EU regulatory frameworks that the majority of contract manufacturers completely ignore.
We contribute to defining the rules' application rather than merely adhering to them.
Pinus sylvestris
A Rare Example of Scientific-Led Contract Manufacturing
As one of the few European CMOs actively involved in regulatory research and scientific dossier development, BF-EssE stands out from the majority of private-label manufacturers, who typically rely on off-the-shelf formulations and market trends.
Our work with Pinus sylvestris serves as an example of how regulatory expertise and in-depth ingredient knowledge may open up new, premium, and compliance botanicals for ethical brands.
This is intellectual leadership, not only conformity.
Our work with Pinus sylvestris serves as an example of how regulatory expertise and in-depth ingredient knowledge may open up new, premium, and compliance botanicals for ethical brands.
This is intellectual leadership, not only conformity.
What Does “Non-Novel” Status Mean?
According to EU Regulation (EU) 2015/2283, an ingredient not consumed “significantly” before 15 May 1997 is considered “novel” and requires a full EFSA safety review before market entry.
- But through a coordinated submission supported by data from Lithuania, BF‑EssE helped confirm that pine components — including needles, cones, and syrup — were historically consumed in the EU, and are therefore classified as non-novel in both foods and food supplements.
-
This means:
- No EFSA pre-market authorisation is needed
- The ingredient is legally usable across all EU member states
- The decision stems from a formal consultation conducted under Article 4 of Implementing Regulation (EU) 2018/456, submitted through German authorities, with evidence provided by national food history databases in Latvia and Lithuania.
-
Which Pine Ingredients Are Included?
- Pine cones (preserved or reduced)
- Pine syrup (from cones or shoots)
- Pine needle extract (aqueous and low-temperature processed)
- Pine bud infusions
- Non-medicinal pine bark extract
More then a CMO !
Our team at BF-EssE does more than just create and fill capsules; we also pave the way for future chemicals that others won't handle in terms of regulations.
We take pride in being one of the few CMOs in the EU with a track record of directly consulting regulators and validating ingredients.
From pine to peptides, we are still working to introduce botanically fascinating, legally safe, and scientifically sound components to the market, supported by open science and thorough documentation.
We take pride in being one of the few CMOs in the EU with a track record of directly consulting regulators and validating ingredients.
From pine to peptides, we are still working to introduce botanically fascinating, legally safe, and scientifically sound components to the market, supported by open science and thorough documentation.
Conclusion
Brands can now safely create pine-based (Pinus sylvestris) products without worrying about regulatory challenges because Pinus sylvestris has been verified as non-novel.
This once-uncertain component is now completely released for compliant innovation throughout Europe, thanks to BF EssE's scientific effort and regulatory knowledge.
BF-EssE is the partner you need if you want someone who leads with regulatory intelligence in addition to manufacturing.
This once-uncertain component is now completely released for compliant innovation throughout Europe, thanks to BF EssE's scientific effort and regulatory knowledge.
BF-EssE is the partner you need if you want someone who leads with regulatory intelligence in addition to manufacturing.
Pinus sylvestris—Current Novel Food Status
Not Novel for Food or Food Supplements
A recent consultation request in Germany (via Regulation 2018/456, Article 4) confirms that Pinus sylvestris products like preserved pine cones and syrup are classified as “Not Novel” both for food and for use in food supplements
Specifically:
“The preserved pine cones (Pinus sylvestris) for consumption as such as well as the syrup produced when boiling, are not novel.” Food Safety
This means that — as of now — these pine products do not require novel food approval under the EU framework.
Not Novel for Food or Food Supplements
A recent consultation request in Germany (via Regulation 2018/456, Article 4) confirms that Pinus sylvestris products like preserved pine cones and syrup are classified as “Not Novel” both for food and for use in food supplements
Specifically:
“The preserved pine cones (Pinus sylvestris) for consumption as such as well as the syrup produced when boiling, are not novel.” Food Safety
This means that — as of now — these pine products do not require novel food approval under the EU framework.
EFSA database approval
What BF-EssE can do for you
Whether your ingredient is verified as novel or you are creating new extracts, isolates, or biotechnologies, BF-EssE can assist you with the entire clearance process.
BF‑EssE can help you navigate the full clearance procedure if your ingredient has been verified as novel or if you're developing new extracts, isolates, or biotechnologies.
We provide comprehensive regulatory and technical assistance for:
production of a scientific dossier (identification, composition, safety, and usage history)
Consultations with authorities before to filing
Coordination of EFSA submissions
Review of compliance and, if necessary, reformulation
We work with regulatory advisers, food scientists, and EU law experts to ensure your novel food product meets the strictest standards and has the best chance of being authorized.
We provide comprehensive regulatory and technical assistance for:
production of a scientific dossier (identification, composition, safety, and usage history)
Consultations with authorities before to filing
Coordination of EFSA submissions
Review of compliance and, if necessary, reformulation
We work with regulatory advisers, food scientists, and EU law experts to ensure your novel food product meets the strictest standards and has the best chance of being authorized.
FAQ: Pinus sylvestris and Novel Food Compliance
Yes. As of 2025, several components of Pinus sylvestris — including needle extract, syrup, and cones — are officially classified as non-novel and legally permitted in food and food supplements within the European Union.
Yes. BF‑Esse led the formal consultation under Article 4 of Regulation 2018/456, with historical consumption evidence from Latvia and Lithuania. The status “Not Novel” was confirmed by German authorities in coordination with the EU Commission.
Yes. BF‑EssE produces and supplies compliant pine needle extract for use in food supplements and offers full support for label compliance, dosage form development, and regulatory positionin
Absolutely. We support clients with novel food strategy, dossier writing, consultation submissions, and EFSA coordination—from early-stage formulation to full EU market clearance.