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Compliance with EU Regulations
Responsible Manufacturer
As the responsible manufacturer of Rhino Horn (adult and Junior), Somamed AS is obliged to see to that these products and their packaging comply with the relevant EU regulations.
EU Regulation of the Product
Rhino Horn (adult and Junior) is a medical device (MD) and therefore, it is regulated by:
“Regulation (EU) 2017/745 on Medical Devices” (MDR)
EU Regulation of the Packaging
Rhino Horn is a medical product that comes in a consumer packaging. It is transported in a transport packaging for wholesalers. Therefore, Somamed AS is also responsible for compliance with the packaging regulation:
“Regulation (EU) 2025/40 on Packaging and Packaging Waste” (PPWR).
Regulation (EU) 2017/745 on Medical Devices (MDR)
Declaration of Conformity No. 20250228-01
This EU declaration of conformity is issued under the sole responsibility of the manufacturer, Somamed AS, under the requirements set out in Annex IV.
Somamed AS – The responsible manufacturer of Rhino Horn
Postal address P. O. Box 200, 1451 Nesoddtangen, Norway
Physical address Øvreveien 38, 1452 Nesoddtangen, Norway
Telephone number +47 97518789 – email post@somamed.com.
Device and trademark: Rhino Horn
Trademark registration number for Norway: 287762.
Trademark registration number for the EU: 003036365.
Rhino Horn is further registered as a trademark in the USA, Canada, Russia, Belarus, Armenia, Kazakhstan, Kyrgyzstan, Thailand and Vietnam.
| Model | Basic UDI DI |
| Rhino Horn Blue | 709000149RHPM |
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| Rhino Horn Red | 709000149RHPM |
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| Rhino Horn Junior | 709000149RHPM |
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| Rhino Horn Orange | 709000149RHPM |
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| Rhino Horn Green | 709000149RHPM |
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Classification: Class I (non-sterile, non-measuring)
Classified according to the rules in Annex VIII, Chapter III
Rule 1 / alternatively rule 5, the first and the second stroke
I declare that the content of this declaration conforms to the requirements of Regulation (EU) 2017/745.
Signed at Nesoddtangen, Norway, on February 28, 2025, for
Somamed AS
Sondre Farestveit, CEO
End User Packaging and Transport Packaging
Regulation (EU) 2025/40 on Packaging and Packaging Waste (PPWR)
Declaration of Conformity (DoC) No. 2026-1
This DoC is issued by Somamed AS, P.O. Box 200, 1421 Nesoddtangen, NO985029504, as the sole responsible manufacturer of Rhino Horn and declares conformity with Regulation (EU) 2025/40 on Packaging and Packaging Waste (PPWR.) as shown below.
Table I: List of materials and technical specifications – Rhino Horn and consumer packaging:
| Item | Made of | Dimension (mm) | Weight (g) | Tests / characteristics | Results |
| Rhino Horn blue, red, green and orange |
HDPE | L: 161 W: 74 H: 96 |
33 | Appendix A REACH SVHC 2025 Rhino Horn |
No hazardeous ingredient |
| Rhino Horn Junior |
HDPE | L: 141 W: 65 H: 85 |
27 | Appendix A REACH SVHC 2025 Rhino Horn |
No hazardeous ingredient |
| Rhino Horn Spoon |
HIPS | L: 140 W: 34 H: 13.5 |
7 | Appendix B REACH SVHC 2025 Rhino Horn Spoon |
No hazardeous ingredient |
| Rhino Horn Packaging |
DUPLEX paperboard 350 GSM |
L: 97 W: 75 H – product.:155 H – with hang tab: 164.5 |
33 | Appendix C-1 and C-2 REACH 2025 |
No hazardeous ingredient |
| Rhino Horn Junior Packaging |
DUPLEX paperboard 350 GSM |
L: 85.5 W: 66.5 H – product.: 140 H – with hang tab: 151 |
27 | Appendix C-1 and C-2 REACH 2025 |
No hazardeous ingredient |
| Ink for printing | Waterbased ink | Appendix D REACH SVHC 2026 Ink used |
No hazardeous ingredient | ||
| Ink for printing | Waterbased ink | Appendix E RoHs 2026 Ink used |
No hazardeous ingredient | ||
| Coating material |
Waterbased coating | Appendix F MSDS APT-8905 Paper laminating adhesive |
Non-hazardous ingredients: 100% |
Table II: List of materials and technical specifications – Transport packaging:
| Corrugated cardboard box (transport wholesale box) |
Recycled 5 layers of corrugated card board: TL150/XEO115/XEO115/ XEO115/TL150 |
L: 500 W: 400 H – product: 675 Thickness: 7 |
1400 | Appendix G | |
| Pallet | Wood | L: 1200 W: 1000 H: 120 |
16000 | Heat Treatment | |
| Strapping | Polypropylen | 2 horizantal L: 6320 – W:15 2 vertical straps: L: 6820 – W. 15 |
100 (horizontal) 150 (vertical) |
Consumer packaging
The consumer packaging comes in different versions. The specifications are identical except for size, language and colour. Each version is marked with a unique batch number and production date for unambiguous identification and traceability.
The adult versions are:
(As soon as a version has been updated to comply with the new PPWR regulation, there will be an active link to show the design file of the version)
- Nordic version
- Language priority: Norwegian – blue, red
- Language priority: Danish – blue, red
- Language priority: Swedish – blue, red
- Finnish version blue, red, orange, green
- German version blue, red
- Benelux version blue, red
- French version blue, red, junior, user instructions
- Spanish version blue, junior, user instructions
- Central European version blue, red, green
- Southeastern European version blue, red
The Junior versions are:
- Nordic version
- Language priority: Norwegian
- Language priority: Danish
- Language priority: Swedish
- German version
- Benelux version
- French version, user instructions
- Spanish version, user instructions
- Central European version
Heavy metals in packaging
The REACH tests referred to in appendix C guarantees that no heavy metal and no substance of very high concern (SVHC) is present in the material.
Recyclability of the packaging
Since the packaging material is absolutely toxic-free, it is recyclable at the highest level, Grade A (Annex II, table 3, according to criteria in table IV).
Conformity with the specified requirements in articles 5 through 12:
Article 5 Requirements for substances in packaging
According to the REACH test for Duplex Paper 350 (the material used for Rhino Horn consumer packaging) and the guaranteed recyclability of the corrugated cardboard (the material used for transport packaging), no SVHC is present in the packaging. Additionally, this is confirmed for the ink used for printing through a REACH SVHC test and for the coating material used through the MSDS, saying that no hazardous ingredient is present according to RoHS.
Article 6 Recyclable packaging
Rhino Horn adult and Junior: Duplex Paper 350 gsm is produced with one layer consisting of recycled paper mass and one layer consisting of new paper raw material. The entire Duplex Paper is 100 % recyclable. The ink and coating used in the production of the consumer packaging are water based and therefore, it will cause no problem for its recyclability. Recycled Duplex Paper will become high quality raw material for future production. The recyclability is estimated to grade A according to Annex II, table 3, following the criteria in table IV.
Transport packaging: The corrugated cardboard box is entirely made from recycled paper materials and may therefore also be recycled again without limitations. Recycled TL/XEO115/XEO115/XEO115/TL150 will become high-quality raw material for future production of a similar article. The recyclability is estimated to grade A according to Annex II, table 3, following the criteria in table IV.
Article 7 Minimum recycled content in plastic packaging
Not relevant.
Article 8 Biobased feedstock in plastic packaging
Not relevant.
Article 9 Compostable packaging
Not relevant.
Article 10 Packaging minimisation
By January 1, 2030, packaging must be designed with its weight and volume reduced to the minimum, necessary to ensure its functionality.
Already at this moment, the consumer packaging for the adult and Junior Rhino Horn is minimised as much as possible.
You may compare the dimensions of the packaging (P) and Rhino Horn adult (RH):
Length: P 155-164 mm / RH 161 mm. Packaging length fits the length of Rhino Horn
Width: P 75 mm / RH 74 mm. Packaging is 1 mm wider than the Rhino Horn
Height: P 97 mm / RH 96 mm. Packaging is 1 mm deeper than the Rhino Horn
If you compare the dimensions of the packaging for Rhino Horn Junior (PJ) and Rhino Horn Junior (RHJ):
Length: PJ 140-151 mm / RHJ 141 mm. Packaging size is from –1 to +10 mm different from the RHJ
Width: PJ 66,5 mm / RHJ 65 mm. Packaging is 1.5 mm wider than the RHJ
Height: PJ 85.5 mm / RHJ 85 mm. Packaging is 0.5 mm deeper than the RHJ.
Conclusion: The packaging for the versions Rhino Horn adult and Junior has been minimized as much as possible.
Article 11 Reusable packaging
Not relevant.
Article 12 Labelling of packaging
No later than August 12, 2028, the new packagings for Rhino Horn adult and Rhino Horn Junior will be equipped with a triangular pictogram indicating the recyclability of the packaging, PAP 21. The national preferred pictogram indicating how the packaging should be treated as waste will also be printed on the packaging. The packaging should be sorted as non-corrugated paperboard.
A QR code on the packaging will link to a webpage on Somamed AS’ website with information on both the product and the packaging. This page will contain the DoC for the product as well as the DoC for the packaging.
Personal data collected by cookies will not be displayed with other information intended for sales or marketing purposes.
August 12, 2026, signed in Nesoddtangen by
Sondre Farestveit for Somamed AS
The Rhino Horn is easy to use, but we do advise you to read the instruction pamphlet before beginning.
The Rhino Horn is designed, manufactured and distributed by
P. O. Box 2599 Solli
N-0203 Oslo • Norway
Phone +47 905 15 558
E-mail post@somamed.com
www.somamed.com
Made of recyclable hard plastic (HDPE)
Totally free from any dangerous chemical – has passed the REACH 247 test
No Cadmium – No Bisphenol A – No phthalates