Kiri

Hi Helina,

Yesterday it was removed, but today morning my colleague turned it on back and then read my email about this issue.

It‘s turned off right now. Sorry for inconvienence.

Thanks for noticing.

Hello,

Thank you for your reply, the Agency acknowledges your confirmation that the product will be removed from the market until the relevant requirements are met. On the website the product „Padi NORA NATUR“ is still available, when do you plan to remove the misleading information from the website?

Sincerely,

Hi Helina,

Thank you for your letter.

First of all, I want to apologize, that we missed product labeling regulations. I can admit, that currently our product labeling don‘t meet those regulations.

1 In Pillow NORA NATUR core production formula is used „Ultrafresh DW-30“ material, which contains these biocides:

1. A. Zinc pyrithione (EC-No 236-671-3)

2. B. Thiabendazole (EC-No 205-725-8)

2 Attaching photos of Nora Natur labeling as requested.

3 In your motion mentioned linen cover fabric and ricin oil as materials which we use in product descriptions when talking about antibacterial environment has not any biocides and this conclusion as feature made by marketing team was based on public opinion and material organic features not scientific reasoning.

4 I admit that we didn‘t labeled Nora natur pillow as required by Estonia law and without waiting for your answer, we already taken down this product from assortment, till we close this matter AND fill needed registrations and get approval that labeling is correct;

5 Finally not sure if needed, but adding dust mite certificate of pillow core; Note: Pillow core producer is Vita Baltic International, so as written in sertificate. This company is our supplier.

6 Thank you very much for guidelines and requirements. According to them we are preparing right labeling of the product;

Thank you in advance, if you need anything more – let me know.

Saulius Jakutis

Projektų vadovas | PM

+370 614 39159

saulius@lonas.lt

www.lonas.lt

Dear Saulius Jakutis,

An inquiry was forwarded to the Estonian Health Board enforcement department regarding the product sold on the Lonas.ee website. Since biocidal claims have been made about the product, please specify which active ingredient/ingredients have been used to process the pillow. Instructions regarding products treated with biocides have been added in attachment.

The person responsible for the placing on the market of a treated article shall ensure that the label provides the information listed in the Regulation (EU) No 528/2012 second subparagraph, where:

• * a statement that the treated article incorporates biocidal products;

• * where substantiated, the biocidal property attributed to the treated article;

• * without prejudice to Article 24 of Regulation (EC) No 1272/2008, the name of all active substances contained in the biocidal products;

• * the name of all nanomaterials contained in the biocidal products, followed by the word ‘nano’ in brackets;

• * any relevant instructions for use, including any precautions to be taken because of the biocidal products with which a treated article was treated or which it incorporates.

Please send photos of the product packaging and label including all the necessary information.

A treated article shall not be placed on the market unless all active substances contained in the biocidal products that it was treated with or incorporates are included in the list drawn up in accordance with Regulation (EU) No 528/2012 Article 9(2), for the relevant product-type and use, or in Annex I, and any conditions or restrictions specified therein are met. Biocides in the review program have different requirements in the member states, in Estonia biocides containing such active ingredients must be applied for a registration certificate (bpr@terviseamet.ee).

Board expects an answer at the earliest, but no later than 26.03.24

Hello Helina,

Sorry for delayed reply. We had management change in Estonia and your letter didn‘t went to right persons.

First of all, is it ok to communicate in english?

As I understand via google translate help, we don‘t provide some info for the product, which is required under Estonia law; What time you can give me to gather all info?

Saulius Jakutis

Projektų vadovas | PM

+370 614 39159

saulius@lonas.lt

www.lonas.lt

Tere!

Amet edastas 01.03.24 ettevõttele kirja nr 12.10-2/24/134-1, millele vastamise tähtaeg (15.03.2024) on möödunud. Millised on olnud ettevõtte vahepealsed tegevused?

Lugupidamisega

Helina Tali

vaneminspektor

Põhja regionaalosakond

+372 5841 5664

helina.tali@terviseamet.ee

Käesolev kiri on konfidentsiaalne ning mõeldud kasutamiseks kirja päises nimetatud isikule/asutusele. Käesoleva kirja mistahes viisil kasutamine või kopeerimine isiku poolt, kes ei ole märgitud selle adressaadiks, on keelatud. Kui te olete saanud käesoleva kirja ekslikult, palume sellest koheselt teavitada kirja saatjat ning kustutada saadud kiri koos kõikide lisadega.