WALTEK Analysis of The Amendment Regulation (EU) 2019/1338 was published in the Official Journal of the European Union on August 9, 2019. The regulations mention:
Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (EU) No.10-2011 (FCM Substance No. 1059, CAS No. 147398-31- The authorization of 0) requires that the total migration of all oligomers with a molecular weight below 1000 Da does not exceed 5.0 mg/kg of food or food simulant.
Because of the complexity of the analytical methods for determining the migration of these oligomers, the competent authorities are unable to describe these methods. Without this description, the competent authority could not verify whether the migration of oligomers from materials or articles met the migration limits of these oligomers. Therefore, Annex I of Regulation No. 10/2011 (EU) was amended accordingly and entered into force on the twentieth day after publication in the Official Journal of the European Union.
In Annex I of Regulation (EU) No 10/2011, the entry in Table 1 for FCM Substance No 1059 is replaced by the following:
| Substance number | CAS number | Substance | Remarks |
| 1059 | 147398-31-0 | Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) | Can be used alone or in combination with other polymers, up to 6 months and / or 6 months or longer under contact conditions, all foods at room temperature or lower, including hot or short heating stage. The migration of all oligomers with a molecular weight below 1 000 Da must not exceed 5.0 mg/kg of food. |
Food contact plastic materials and articles that meet the applicable regulations (EU) No 10/2011 before the entry into force of this regulation may be placed on the market by August 29, 2020 and may remain on the market until they are used up in the market.
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